As of 28 September 2026, FDA's Animal Drugs @ FDA database (the Green Book) lists 53 animal drug applications with ivermectin as an active ingredient, of which 46 are approved — 21 NADAs and 25 ANADAs — and 7 carry the status "Voluntary Withdrawn." That approved set is what this index covers: every dosage form FDA has cleared for animals in the United States, from the 1% ivermectin injection used in cattle and swine to heartworm chewables for dogs and an otic suspension for cats. Every product named here is labeled for animal use only. None of them is approved for people, and FDA states in its consumer update on ivermectin (content current as of 5 April 2024) that "Animal ivermectin products are different formulations than those approved for humans," with the safety of those formulations in people not known. If you are trying to understand how animal labels differ from human ones, start there.

Rows of plain unbranded veterinary parasiticide bottles and paste syringes on a wooden farm-supply shelf in warm afternoon light

The numbers below come from primary records only: the eCFR text of the relevant 21 CFR sections (retrieved 22 and 28 September 2026), Green Book application records (retrieved 28 September 2026), and current DailyMed labels with their own revision dates. Where a figure exists in regulation and on a label, both are given.

Key takeaways

  • Enumerating the species field of all 53 Green Book ivermectin records on 28 September 2026 yields nine labeled species: cattle, swine, sheep, horses, reindeer, American bison, ranch-raised foxes, dogs and cats.
  • Residue tolerances exist for only five food species — American bison, cattle, reindeer, sheep and swine (21 CFR 556.344(b)).
  • Slaughter withdrawals differ by route, not just by species: injection 35 days in cattle, pour-on 48 days, the 0.153% cattle paste 24 days, the sustained-release bolus 180 days.
  • No FDA-approved ivermectin product in the US has an established milk withholding period; labels prohibit use in dairy cattle of breeding age instead.
  • Prescription status is not uniform: ivermectin paste carries no prescription restriction in 21 CFR 520.1192, while ivermectin tablets and chewables (520.1193) and ivermectin liquid for horses (520.1195) are restricted to use by or on the order of a licensed veterinarian.

How to read this index: what FDA approval of an animal drug actually means

A rancher drawing a dose of clear injectable cattle parasiticide into a syringe beside a squeeze chute in a barn

An approval is specific. It attaches to one application (an NADA for a pioneer product, an ANADA for a generic copy), one sponsor, one concentration, one route, a named species list, named parasites, and a stated withdrawal. Use outside those boundaries is "extralabel use," defined at 21 CFR 530.3(a) as use of a drug in an animal "not in accordance with the approved labeling," including use in species not listed, for indications not listed, or at other dosages or routes.

Approval also does not settle prescription status by itself. Under 21 U.S.C. 353(f)(1), an animal drug that is not safe except under a veterinarian's professional supervision may be dispensed only on a veterinarian's lawful order, and 353(f)(4) requires the caution statement on the label — while making it misbranding to put that statement on a product it does not apply to. That is why some of the products below sit on shelves at feed and farm retailers while others do not; if you are comparing what farm stores stock against this list, the prescription column is the reason for most of the gaps.

One label sentence is easy to miss. Non-prescription anthelmintic animal drugs must bear, conspicuously, the statement required by 21 CFR 500.25(b): "Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism."

Master table: product, sponsor, NADA/ANADA, species, concentration, route, withdrawal

Pour-on cattle parasiticide being applied in a narrow strip along the topline of a beef cow in a chute

All rows are animal-use products. Withdrawal figures are label and regulation values for the labeled species and route, not pharmacokinetic half-lives; the underlying meat and milk withdrawal intervals are set per product.

Product Sponsor / labeler Application Species Concentration Route Slaughter withdrawal
IVOMEC Injection for Cattle and Swine Boehringer Ingelheim Animal Health USA NADA 128-409 Cattle, swine, reindeer, American bison; ranch-raised foxes and piglets ≤70 lb at 0.27% 1% (10 mg/mL); 0.27% (2.7 mg/mL) Subcutaneous Cattle 35 d; swine 18 d; reindeer and bison 56 d
AGRI-MECTIN Injection Huvepharma ANADA 200-429 Cattle, swine, reindeer, bison 1% Subcutaneous 35 / 18 / 56 d
NOROMECTIN Injection (also marketed as VETRIMEC 1%) Norbrook Laboratories ANADA 200-437 Cattle, swine, reindeer, bison 1% Subcutaneous 35 / 18 / 56 d
BIMECTIN Injection (also marketed as IVERMAX) Bimeda ANADA 200-447 Cattle, swine, reindeer, bison 1% Subcutaneous 35 / 18 / 56 d
IVOMEC Plus Boehringer Ingelheim NADA 140-833 Cattle 1% ivermectin + 10% clorsulon Subcutaneous 21 d
BIMECTIN PLUS (also IVERMAX PLUS) Bimeda ANADA 200-450 Cattle 1% + 10% clorsulon Subcutaneous 21 d
IVOMEC Pour-On Boehringer Ingelheim NADA 140-841 Cattle 5 mg/mL (0.5%) Topical, topline 48 d
Ivermectin Cattle Pour-On (also ECOMECTIN) Durvet / Huvepharma ANADA 200-348 Cattle 5 mg/mL Topical 48 d
Ivermectin solution (pour-on) Durvet ANADA 200-318 Cattle 5 mg/mL Topical 48 d
IVOMEC Drench for Sheep Boehringer Ingelheim NADA 131-392 Sheep 0.08% (0.8 mg/mL) Oral drench 11 d
Ivermectin Sheep Drench (also Privermectin) Durvet / First Priority ANADA 200-327 Sheep 0.08% Oral drench 11 d
IVOMEC Cattle Paste 0.153% — NADA 137-006 Cattle 0.153% Oral paste 24 d
IVOMEC Sustained-Release Bolus — NADA 140-988 Ruminating calves 275–660 lb 1.72 g per bolus Oral bolus 180 d
IVOMEC Premix for Swine — NADA 140-974 Swine 0.6% Type A (2.72 g/lb) Medicated feed 5 d
BMD / IVOMEC Premix for Swine — NADA 141-097 Swine 0.6% ivermectin + bacitracin MD Medicated feed See 21 CFR 558.300
ZIMECTERIN Paste 1.87% Boehringer Ingelheim NADA 134-314 Horses 1.87% Oral paste None; not for horses intended for human consumption
DuraMectin, Bimectin, Phoenectin, Equell pastes Durvet/Bimeda, Bimeda, Farnam, Virbac ANADA 200-390, 200-326, 200-286, 200-320 Horses 1.87% Oral paste None; food-use prohibition
Zimecterin-EZ meal Farnam Companies NADA 141-241 Horses 0.6% (6 mg/g) Oral top-dress None; food-use prohibition
SparMectin-E Liquid for Horses (Rx) Sparhawk Laboratories ANADA 200-341 Horses 10 mg/mL Stomach tube or oral drench None; food-use prohibition
ZIMECTERIN GOLD Boehringer Ingelheim NADA 141-214 Horses 1.55% ivermectin / 7.75% praziquantel Oral paste None; food-use prohibition
EQUIMAX Virbac AH (current SPL labeled by Bimeda) NADA 141-215 Horses 1.87% / 14.03% praziquantel Oral paste None; food-use prohibition
HEARTGARD / HEARTGARD 30 tablets (Rx) — NADA 138-412 Dogs 68 mcg per tablet Oral Not a food species
HEARTGARD Chewables (Rx) — NADA 140-886 Dogs ≥6 weeks 68 / 136 / 272 mcg Oral Not a food species
HEARTGARD Plus (Rx) — NADA 140-971 Dogs 68/57, 136/114, 272/227 mcg ivermectin / mg pyrantel Oral Not a food species
HEARTGARD for Cats (Rx) — NADA 141-078 Cats ≥6 weeks 55 / 165 mcg Oral Not a food species
IVERHART PLUS (Rx) Virbac AH ANADA 200-302 Dogs ≥6 weeks 68 / 136 / 272 mcg Oral Not a food species
Tri-Heart Plus (Rx) Intervet (ANADA held by Diamond Animal Health) ANADA 200-338 Dogs ≥6 weeks ivermectin / pyrantel Oral Not a food species
IVERHART MAX Chew (Rx) Virbac NADA 141-441 Dogs ≥8 weeks 34 / 68 / 136 / 272 mcg + pyrantel + praziquantel Oral Not a food species
Panacur Plus (Rx) Intervet NADA 141-286 Adult dogs 68 mcg + 1.134 g fenbendazole + 57 mg praziquantel; or 27 mcg + 454 mg + 23 mg Oral chewable Not a food species
Advantage DUO (Rx) Elanco US NADA 141-208 Dogs 100 mg/mL imidacloprid + 800 mcg/mL ivermectin Topical Not a food species
ACAREXX otic suspension (Rx) Boehringer Ingelheim NADA 141-174 Cats ≥4 weeks 0.01%, 0.5 mL tube Otic Not a food species

Injectable products, including the reindeer and American bison approvals

A woman administering an oral paste dewormer syringe to a bay horse in a stable doorway

The injectable category is codified at 21 CFR 522.1192. The regulation fixes the cattle dose at 200 micrograms per kilogram of body weight by subcutaneous injection and states: "Do not treat cattle within 35 days of slaughter." Swine are dosed higher — 300 µg/kg subcutaneously — with an 18-day withdrawal, and the swine limitations paragraph is that one sentence, with no dairy or veal clause.

The pioneer product is IVOMEC Injection for Cattle and Swine, NADA 128-409, whose current DailyMed SPL (effective 1 July 2026; package insert Rev. 08/2023) describes it as a ready-to-use sterile solution containing 1% ivermectin, 40% glycerol formal and propylene glycol — which is what "ivermectin injection 1%" refers to: 10 mg per mL, "sufficient to treat 110 lb (50 kg) of body weight (maximum 10 mL per injection site)." In swine, one mL treats 75 lb. The label restricts the route absolutely: "This product is not for intravenous or intramuscular use." Pack sizes on that label are 50 mL, 200 mL, 500 mL and 1000 mL, so the "ivermectin injectable 500ml" bottle is one of four approved presentations; the 50 mL bottle is to be used within 6 months of first puncture and punctured no more than 12 times. Green Book record 460 also documents a 0.27% (2.7 mg/mL) strength under the same NADA, for piglets of 70 pounds or less and for ranch-raised foxes.

Reindeer, bison and foxes

Under the label's "Special Minor Use" section, ivermectin injection is approved in reindeer for warbles (Oedemagena tarandi) and in American bison for grubs (Hypoderma bovis), both at 200 micrograms per kilogram subcutaneously, with the residue warning "Do not treat reindeer or American bison within 8 weeks (56 days) of slaughter." The regulation words the two differently — bison "within 56 days of last treatment," reindeer "within 56 days of slaughter" — but the interval is the same. Paragraph (e)(6) approves ranch-raised foxes for ear mites (Otodectes cynotis) at 200 µg/kg, repeated in 3 weeks, and that paragraph ends without any limitations subparagraph, so no withdrawal is stated for foxes.

Emergency use authorizations in 2026

FDA issued an Emergency Use Authorization (EUA 006689) for Ivomec injection against New World screwworm on 5 February 2026, for prevention of screwworm myiasis in cattle when given within 24 hours of birth, at castration, or at the appearance of a wound. FDA's FOI summary states the withdrawal "is 35 days, as established under NADA 128-409" — an emergency authorization did not relax the residue standard. A second ivermectin cattle EUA, 006729 for Bimectin injection (Bimeda Animal Health Ltd.), was authorized on 27 August 2026 with the same 35-day figure. Two wording differences matter: the EUA fact sheets bar use in "female dairy cattle producing milk for human consumption" (the approved label bars all female dairy cattle of breeding age), and they extend the veal restriction to "calves born to treated cows."

Species warning printed in the regulation

21 CFR 522.1192(d)(2) requires labeling to bear the precaution: "This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result." The IVOMEC label repeats it and adds that the product was developed specifically for cattle, swine, reindeer and American bison only.

Pour-on and topical solutions (cattle only)

A store clerk comparing two identical-looking plain bottles of livestock wormer at a farm store counter under a lit PHARMACY sign

21 CFR 524.1193 specifies 5 milligrams of ivermectin per mL, applied at "One mL per 22 pounds (0.5 milligram per kilogram) of body weight applied topically to the back of the animal," with the limitation "Do not treat cattle within 48 days of slaughter. Do not use on female dairy cattle of breeding age or on calves to be processed for veal." The IVOMEC Pour-On SPL (NADA 140-841, Rev. 07/2024) agrees: 48 days, applied "along the topline in a narrow strip extending from the withers to the tailhead." Generic pour-ons verified for this index — Durvet's Ivermectin Cattle Pour-On under ANADA 200-348 (SPL revised 4/2026) and Durvet's ivermectin solution under ANADA 200-318 — carry the same 48 days.

The topical route also has a different parasite list from the injection: per 21 CFR 524.1193(d)(2), the pour-on indication names horn flies (Haematobia irritans) and the biting louse Damalinia bovis, which the injection indication does not. That, and the longer withdrawal, are the two practical differences between the routes; there is more detail in our page on pour-on products for cattle.

Oral drenches and feed premixes

21 CFR 520.1195 covers "Ivermectin liquid" at two strengths: 10 mg/mL and, as a micellar solution, 0.8 mg/mL. The 0.8 mg/mL product is the sheep drench — dosed at "200 mcg/kg (3 mL/26 pounds) of body weight as a single dose oral drench," with an 11-day slaughter withdrawal. The IVOMEC Drench for Sheep label (NADA 131-392, 0.08% solution, SPL effective 31 October 2025) states the same 11 days, and the words "milk" and "dairy" do not appear anywhere on it, nor anywhere in 21 CFR 520.1195. The regulation itself carries the species warning: "For use in sheep only. Do not use in other animal species as severe adverse reactions, including fatalities in dogs, may result." Generic drenches under ANADA 200-327 (Durvet) repeat the 11 days; one relabeled SPL under that same ANADA, Privermectin Drench for Sheep, contains no residue warning at all, which is a reason to read the specific container in hand rather than a sibling label.

Two other oral forms are cattle-only. The sustained-release bolus (21 CFR 520.1197, NADA 140-988) contains 1.72 grams of ivermectin, is limited to ruminating calves older than 12 weeks weighing 275 to 660 lb, and carries a 180-day withdrawal — the longest in the ivermectin set. For horses, 21 CFR 520.1194 approves an "ivermectin meal" at 0.6% (6 mg per gram), given at 136 mcg per pound (300 mcg/kg) on about 2 lb of grain or sweet feed; note the oral equine dose rate is not uniform across dosage forms.

Medicated feed is approved only for swine. 21 CFR 558.300 specifies "Type A medicated article containing 2.72 grams ivermectin per pound," with six approved rows running from 1.8 to 120 grams per ton, each delivering 0.1 mg/kg of body weight per day fed as the only feed for 7 consecutive days, then "Withdraw 5 days before slaughter." The swine claims include kidneyworms (Stephanurus dentatus) and threadworms, with prevention of transmission of infective larvae to piglets via colostrum or milk when fed during gestation. FDA states flatly on its New World screwworm drug page that "No medicated feeds containing ivermectin or doramectin are approved for any indication for cattle or wildlife in the U.S." — a sentence limited to cattle and wildlife, since the swine premix is approved.

Pastes and oral products approved for horses

21 CFR 520.1192 is titled "Ivermectin paste" and approves two strengths: 1.87 percent and 0.153 percent. The horse dose is stated as "200 micrograms per kilogram (91 micrograms per pound) of body weight," and the limitations paragraph is short: "For oral use only. Do not use in horses intended for human consumption." There is no withdrawal interval for the equine paste because the horse is removed from the food supply instead. The same structure appears on every equine ivermectin form FDA has approved; Durvet's DURAMECTIN Paste 1.87% (ANADA 200-390, SPL effective 10 June 2026), for instance, carries "WARNING: Do not use in horses intended for human consumption" and no residue section at all.

The pioneer paste is ZIMECTERIN 1.87% (NADA 134-314). Its carton states contents "WILL TREAT UP TO 1250 lb BODY WEIGHT," the syringe holds 6.08 g of paste, and each plunger marking delivers enough for 250 lb. Generic 1.87% pastes include ANADA 200-390 (marketed as DuraMectin), 200-326 (Bimectin), 200-286 (Phoenectin) and 200-320 (Equell). On ivermectin paste ingredients: the labeled active is ivermectin at the stated percentage, and what varies between syringes is strength and treat-weight rather than the active. Dosing detail sits in our write-up of the 1.87% equine paste.

The 0.153 percent paste is not a horse product. It is IVOMEC Cattle Paste 0.153% (NADA 137-006), dosed at 23 milligrams per 250 pounds of body weight with a 24-day cattle withdrawal and a prohibition on use in female dairy cattle of breeding age. Confusing the two strengths is the most common error in this category.

Two equine liquids round out the group. SparMectin-E (ANADA 200-341, Sparhawk) is 10 mg/mL "formulated for professional administration by stomach tube or oral drench," and 21 CFR 520.1195(e)(1)(iii) makes the equine liquid prescription-only — the sharpest contrast available within one species, since the paste is unrestricted. Separately, Ivermectin Liquid for Horses (Alberta Veterinary Laboratories Ltd, 10 mg/mL), which received a screwworm EUA on 15 July 2026, is an unapproved animal drug: its DailyMed SPL carries the disclaimer "This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA." That EUA sets no withdrawal and instead states "Do not use in horses intended for human consumption."

Combination products with clorsulon, praziquantel or pyrantel, and why the partner drug is there

Ivermectin's approved claims are for roundworms and arthropods. The partner drugs extend the label to parasites ivermectin is not claimed against.

  • Clorsulon (cattle, injectable). 21 CFR 522.1193 specifies 10 mg/mL ivermectin plus 100 mg/mL clorsulon at 1 mL per 110 lb, with a 21-day withdrawal. The IVOMEC Plus label (NADA 140-833) states the clorsulon dosage it supplies "is effective only against adult liver flukes (Fasciola hepatica)." Counterintuitively, that is shorter than plain IVOMEC's 35 days at the same ivermectin dose. It has moved: the Federal Register of 28 October 2014 (79 FR 64114) records a "Supplemental approval reducing the preslaughter withdrawal period from 49 days to 21 days," the regulation then carried a sponsor split, and as of 19 March 2021 (86 FR 14815) one sponsor still held 49 days. The current eCFR text states a single 21-day figure. Generic BIMECTIN PLUS (ANADA 200-450) also states 21 days.
  • Praziquantel (horses). ZIMECTERIN GOLD (NADA 141-214) is 1.55% ivermectin with 7.75% praziquantel, one syringe treating a 1,250 lb horse at 91 mcg/lb ivermectin and 454 mcg/lb praziquantel, with the tapeworm Anoplocephala perfoliata added to the indication. EQUIMAX (NADA 141-215) pairs 1.87% ivermectin with 14.03% praziquantel, treats up to 1,320 lb, and is labeled safe for horses 4 weeks of age and older.
  • Pyrantel (dogs). HEARTGARD Plus (NADA 140-971) supplies 68 mcg ivermectin with 57 mg pyrantel pamoate, 136 with 114, or 272 with 227. Its indication adds treatment and control of roundworms (Toxocara canis, Toxascaris leonina) and hookworms to heartworm prevention. Generic equivalents are IVERHART PLUS (ANADA 200-302) and Tri-Heart Plus (ANADA 200-338).
  • Three- and four-way dog products. IVERHART MAX Chew (NADA 141-441) adds praziquantel and is recommended for dogs 8 weeks of age or older; Panacur Plus (NADA 141-286, 21 CFR 520.1200) combines ivermectin with fenbendazole and praziquantel; Advantage DUO (NADA 141-208, 21 CFR 524.1140) combines 100 mg/mL imidacloprid with 800 mcg/mL ivermectin topically.

On the ivermectin tablets for animals side, scale matters: 21 CFR 520.1193 sets the canine minimum at 6.0 mcg/kg monthly in dogs 6 weeks and older, and the feline recommended minimum at 24 mcg/kg — one thirty-third and roughly one-eighth of the 200 mcg/kg livestock dose respectively. The indication is prevention, by eliminating the tissue stage of Dirofilaria immitis larvae "for 1 month (30 days) after infection"; these products are not labeled against adult heartworms. ACAREXX otic suspension (NADA 141-174) is indicated for adult ear mites in cats and kittens 4 weeks and older, and its own regulation says "Effectiveness against eggs and immature stages has not been proven."

Species with no approved ivermectin product at all, and what that means legally

Querying Animal Drugs @ FDA on 28 September 2026 for ivermectin plus goats returns zero applications. For poultry, Mercer and colleagues state in their 2025 Frontiers in Veterinary Science paper that ivermectin "is not approved for use via any route of administration in any poultry species in the US," so there is no tolerance for egg or meat residues — consistent with 21 CFR 556.344(b), whose tolerance list covers only bison, cattle, reindeer, sheep and swine.

Legally, that puts any such use inside 21 CFR Part 530, which is a framework for veterinarians. Part 530 applies to extralabel use "by or on the lawful order of a licensed veterinarian within the context of a valid veterinary-client-patient relationship." Section 530.11 lists four uses that are not permitted and that make the drug "unsafe" within the meaning of section 512: the first is extralabel use by a lay person, "except when under the supervision of a licensed veterinarian," and the second — with no exception at all — is extralabel use in or on animal feed. In food species, 530.20(a) requires that no approved animal drug is labeled for the use in the required dosage form and concentration, and obliges the veterinarian to make a careful diagnosis, establish "a substantially extended withdrawal period" supported by appropriate scientific information, identify treated animals, and assure no illegal residues. Records must be kept "for 2 years or as otherwise required by Federal or State law, whichever is greater." Ivermectin does not appear on the prohibited-drug list at 21 CFR 530.41(a).

What replaces a label number in practice is guideline advice. The American Consortium for Small Ruminant Parasite Control's goat chart (edition last updated November 2024) gives the sheep drench used extra-label in goats a 20-day meat and 20-day milk withdrawal, states those figures are FARAD-derived and "may change over time," and stresses that extra-label use is permitted only through a veterinarian within a bona fide relationship. Its sheep chart gives no milk withholds at all, because "uniform milk withholds have not been established in sheep."

For laying hens, the 2025 pilot study dosed injectable ivermectin topically over the jugular vein at 0.4 mg/kg every 7 days for two doses in eight 78-week-old hens. Residues persisted in egg yolk up to 71 days after the last dose, with a terminal elimination half-life of 9.5 days; the authors' estimated egg withdrawal intervals ranged from 57 days to 102 days depending on method, with 81 days by the FDA tolerance-limit approach and 96 days by the half-life multiplier. They state plainly that as a pilot "the study design does not meet the requirements of EMA or FDA for the drug approval process." Those numbers are estimates in a paper, not label intervals — the distinction is developed in our page on species with no approval at all.

Why Durvet, Agri-Mectin, Noromectin and Ivomec labels read almost identically

Because the text is largely fixed upstream of the brand. A generic ANADA must match the pioneer's active ingredient, strength, route and conditions of use, and the withdrawal is written into the regulation rather than chosen by the sponsor: 21 CFR 522.1192 states 35 days for cattle and 18 for swine for every sponsor, and 524.1193 states 48 days for every pour-on sponsor. Some label sentences are mandated word for word — the "fatalities in dogs" precaution at 522.1192(d)(2) and the veterinarian-consultation statement at 500.25(b) — and 21 U.S.C. 353(f)(4) makes it misbranding to add the veterinary caution statement to a product it does not apply to, which is why OTC and Rx labels stay distinct.

So agri-mectin ivermectin (Huvepharma, ANADA 200-429, SPL revised 1/2026), Noromectin (Norbrook, ANADA 200-437) and Bimectin (Bimeda, ANADA 200-447) all state 35, 18 and 56 days, as IVOMEC does. Searches for a durvet ivermectin injection are common, but the Durvet-labeled ivermectin SPLs verified for this index are the sheep drench (ANADA 200-327), the cattle pour-on (ANADA 200-348) and the pour-on solution under ANADA 200-318; we did not verify a Durvet-labeled injectable, so none is listed above.

"Almost identically" is the right phrase, though. The differences are real and occasionally consequential: the generics say "withdrawal period in milk" where IVOMEC Plus says "withdrawal time in milk"; Durvet's ANADA 200-318 label carries the garbled phrase "withdrawal period time in milk"; and the Privermectin drench omits the residue warning its sibling labels carry. Five of these labels — IVOMEC Injection, IVOMEC Plus, IVOMEC Pour-On, IVOMEC Drench and ZIMECTERIN — share an OTHER WARNINGS block opening "Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers." Whatever "ivermectin wormer" you are reading about, that sentence is on the label of the majority of these veterinary ivermectin products.

How this page is maintained and dated

This index is rebuilt from primary records, not from summaries. The regulatory text was read in the eCFR on 22 and 28 September 2026; Green Book application records and the Animal Drugs @ FDA search endpoints were queried on 28 September 2026; DailyMed labels are cited with their own SPL effective dates, the most recent used here being ZIMECTERIN GOLD (31 August 2026), IVOMEC Injection (1 July 2026), DURAMECTIN (10 June 2026) and Durvet's cattle pour-on (9 April 2026). A web check on 28 September 2026 of FDA's screwworm announcements and the relevant eCFR sections found nothing later that changes any figure above.

Two maintenance cautions carry forward. First, Green Book status "approved" does not guarantee a current label exists: as of 28 September 2026, DailyMed's own API reported 117 ivermectin SPLs (database published 25 September 2026), and several approved applications — including IVOMEC Cattle Paste 0.153%, IVOMEC Premix for Swine, the sustained-release bolus, HEARTGARD for Cats, ACAREXX, Zimecterin-EZ, Advantage DUO and Panacur Plus — had no current SPL among them, so their figures here come from the CFR and Green Book. Second, seven applications are marked Voluntary Withdrawn: NADAs 127-443 (Eqvalan Injection), 140-439 (Eqvalan Oral Liquid for Horses), 141-054 (IVOMEC plus LINCOMIX) and 141-421 (Duocare), and ANADAs 200-292 (Iversol Liquid for Horses), 200-299 (Iver-On) and 200-564 (Ivermectin Paste 1.87%). Withdrawn numbers still circulate in older write-ups; they are not current approvals.

Frequently asked questions

What does "1%" mean on an ivermectin injection bottle?

Ten milligrams of ivermectin per mL. The IVOMEC label puts it in usable terms: one mL treats 110 lb (50 kg) in cattle and 75 lb in swine, with a maximum of 10 mL per injection site, given subcutaneously only.

Is there an FDA-approved ivermectin "gel"?

Among the CFR sections verified for this index, the approved oral forms are paste (§520.1192), tablets and chewables (§520.1193), meal (§520.1194), liquid (§520.1195) and a sustained-release bolus (§520.1197). Section 520.1192 covers only the paste dosage form; no section titled "ivermectin gel" appeared among the sections read on 22 September 2026. If a container in front of you says gel, check its application number against the Green Book rather than assuming it maps to the paste approval.

Why is the pour-on withdrawal longer than the injection withdrawal?

Withdrawal intervals are set per product and route from residue-depletion data, not scaled from a half-life. In cattle that produces 35 days for the 1% injection (21 CFR 522.1192), 48 days for the 5 mg/mL pour-on (524.1193), 24 days for the 0.153% paste (520.1192) and 21 days for the ivermectin-clorsulon injection (522.1193).

Does any approved ivermectin product have a milk withdrawal?

No. As of 28 September 2026 no FDA-approved ivermectin product in the US has an established milk withholding period. The labels and regulations instead prohibit use in female dairy cattle of breeding age, in the words of 21 CFR 522.1192(e)(2)(iii): "Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age."

Are any of these products approved for people?

No. Every product in this index is labeled for animal use only and is not approved for human use. FDA's consumer update states that animal ivermectin products are different formulations from the human-approved ones and that their safety in people is not known.

Can a cattle injection be used in goats or chickens?

There is no approved ivermectin product for either species, so any such use is extralabel and falls under 21 CFR Part 530, which permits it only by or on the lawful order of a licensed veterinarian within a valid veterinarian-client-patient relationship; 530.11(a) does not permit extralabel use by a lay person except under a veterinarian's supervision. Several labels and the sheep regulation also warn that use in unlisted species may cause severe adverse reactions, including fatalities in dogs.

Sources