Ivermectin Tablets: Every FDA-Approved Human Product, Strength and Label (2026)

In the United States, ivermectin tablets are prescription-only, and the FDA Orange Book lists them in just two strengths: 3 mg and 6 mg. The brand product is STROMECTOL (ivermectin), approved under NDA 050742 and held by Merck Sharp & Dohme; the rest of the tablet market is generic "Ivermectin Tablets USP" approved under abbreviated applications. The approved indications on every one of those tablet labels are the same two parasitic infections — strongyloidiasis of the intestinal tract and onchocerciasis — and nothing else. If you want the plain-language version of what it is used for and its side effects, that is a separate page; this one stays on the regulatory record.

Pharmacist checking a plain carton of prescription ivermectin tablets at an independent pharmacy counter

Human ivermectin also exists in two topical forms — a 1% cream for rosacea and a 0.5% lotion for head lice — and the lotion is the only human ivermectin product in the United States with over-the-counter status. Everything below is drawn from the FDA Orange Book product data file dated 11 September 2026, from Drugs@FDA application records checked on 28 September 2026, and from the current DailyMed labels, with the exact section names so you can read them yourself. For the paste, pour-on, drench and injectable versions, see the other forms it comes in; those are labeled for animal use only and are not approved for people.

Key takeaways

  • Only three human ivermectin dosage forms are FDA-approved: oral tablet, 1% topical cream, and 0.5% topical lotion (FDA Orange Book product file, 11 September 2026).
  • The Orange Book lists 15 distinct human ivermectin applications across 17 product rows: 13 prescription, 2 over-the-counter, 2 discontinued.
  • Tablet strengths listed in the Orange Book are 3 mg and 6 mg. No 12 mg ivermectin tablet is listed.
  • The STROMECTOL label (revision 09/2024) carries exactly two indications: intestinal strongyloidiasis and onchocerciasis.
  • Animal ivermectin products — paste, injection, pour-on, drench — are labeled for animal use only and are not approved for people.

The three approved human ivermectin products, and what each is approved for

Three unbranded human ivermectin dosage forms - a tablet carton, a cream tube and a lotion tube - arranged on a kitchen table

Counting the FDA Orange Book product file (products.txt) from FDA's Orange Book data files, dated 11 September 2026, three dosage-form-and-route values occur for human ivermectin: TABLET;ORAL, CREAM;TOPICAL and LOTION;TOPICAL. There is no FDA-approved human ivermectin injection, oral solution, oral suspension, paste or ophthalmic product. FDA's online Orange Book search states it is current through September 2026.

Product Application Strength Indication, as the label words it Status
STROMECTOL (ivermectin) tablets, Merck Sharp & Dohme NDA 050742 3 mg (6 mg discontinued) Strongyloidiasis of the intestinal tract; onchocerciasis Prescription
SOOLANTRA (ivermectin) cream, Galderma Laboratories, L.P. NDA 206255, approved 19 December 2014 1% (10 mg per gram) Treatment of inflammatory lesions of rosacea Prescription
SKLICE (ivermectin) lotion NDA 202736, approved 7 February 2012 0.5% Drug Facts "Use: treats head lice" Over-the-counter since 27 October 2020

Across all 17 ivermectin product rows, the marketing-status split is 13 prescription, 2 over-the-counter and 2 discontinued. Both OTC rows are 0.5% lotion. Prescription status is not a retail convention: under 21 U.S.C. 353(b)(4), a prescription drug is misbranded if its label fails to bear at minimum the symbol "Rx only," and a non-prescription drug is misbranded if its label bears it. That is why the STROMECTOL carton prints "Rx only" and the lice lotion carton does not.

STROMECTOL: application number, sponsor, strength, approved indications as written

Two small white ivermectin tablets of different sizes on a pharmacist's oak worktop under warm lamplight

STROMECTOL is approved under NDA 050742, held by Merck Sharp & Dohme. The Drugs@FDA record, checked on 28 September 2026, shows the original approval on 11/22/1996 as a Type 1 - New Molecular Entity under priority review. That original approval was the 6 mg tablet, which is now discontinued. The 3 mg tablet — the strength marketed today — carries an Orange Book approval date of 8 October 1998 and is the reference listed drug.

The indications, in the label's own words

The STROMECTOL Structured Product Label on DailyMed (revision 09/2024) opens its INDICATIONS AND USAGE section with "STROMECTOL is indicated for the treatment of the following infections:" and then lists two: strongyloidiasis of the intestinal tract, and onchocerciasis. There is no third indication on that label.

What the carton and the tablet look like

Under HOW SUPPLIED, the label describes 3 mg tablets as white, round, flat, bevel-edged tablets coded MSD on one side and 32 on the other, supplied under NDC 0006-0032-20 and NDC 0006-0032-01 in unit dose packages of 20. The principal display panel reads "Rx only 20 Tablets (2 Foil Strips of 10 tablets each)." The DESCRIPTION section states that ivermectin is derived from the avermectins, isolated from the fermentation products of Streptomyces avermitilis, and lists five inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder (anhydrous). For how the label converts body weight into tablets, see weight-based dosing on the label.

The generics: what the Orange Book lists, and why box labelling differs

Farm supply shelf of livestock deworming syringes labeled for animal use only, beside a barn doorway

The 11 September 2026 Orange Book file contains 8 ivermectin TABLET;ORAL applications — one NDA and seven ANDAs — comprising 10 product rows. Nine of those rows are prescription and one (STROMECTOL 6 mg) is discontinued. None is over-the-counter.

Application Applicant in the Orange Book Strength Approval date
ANDA 204154 Edenbridge Pharmaceuticals 3 mg 24 October 2014
ANDA 218324 Senores Pharmaceuticals 3 mg 16 October 2024
ANDA 215922 Rubicon Research Ltd 3 mg and 6 mg 22 January 2025
ANDA 218805 Epic Pharma LLC 3 mg 9 September 2025
ANDA 216863 Zydus Lifesciences 3 mg 26 February 2026
ANDA 216808 E5 Pharma LLC 3 mg 9 March 2026
ANDA 218509 Ajanta Pharma Ltd 3 mg 7 April 2026

ANDA 218509 is the most recent tablet approval in the 11 September 2026 Orange Book file. ANDA 215922 is the only ivermectin tablet application with two product numbers, one for each strength; FDA's approval letter of 22 January 2025 found the 3 mg and 6 mg tablets bioequivalent and therapeutically equivalent to STROMECTOL and noted Rubicon's eligibility for 180 days of Competitive Generic Therapy exclusivity.

Why the box in your hand may carry a different company name

The applicant on the Orange Book row is not always the name printed on the carton. Rubicon's tablets reach the US market under the Advagen Pharma label: the DailyMed label for Ivermectin Tablets USP 3 mg and 6 mg reads "Manufactured by: Rubicon Research Ltd., Thane 421506, India. Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA." The wording of the approved uses does not change with the carton. The Epic Pharma generic label begins its indications section "Ivermectin tablets are indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract" — substantively the brand text, with the product name swapped and minor typographic differences.

Strengths that exist and strengths that do not: 3 mg, 6 mg, 12 mg

Person at a home desk consulting a folded medication package insert under a warm desk lamp

Across all 10 ivermectin tablet rows in the 11 September 2026 Orange Book product file — marketed and discontinued alike — only two strength values appear: 3MG and 6MG. That file is a current listing, so it cannot by itself prove that no other strength was ever approved and later delisted; what it establishes is what is listed now.

  • 3 mg — the workhorse strength. STROMECTOL 3 mg plus every generic tablet application listed above.
  • 6 mg — the brand 6 mg tablet is in the discontinued section, and the Orange Book strength field carries the flag "Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons." A 6 mg generic is nonetheless approved and listed as prescription under ANDA 215922 product 002.
  • 12 mg — not an FDA-listed US tablet strength. Where 12 mg appears on the STROMECTOL label, it is a study dose, not a product: the CLINICAL PHARMACOLOGY section reports that after single 12 mg doses in fasting healthy volunteers (a mean dose of 165 mcg/kg), mean peak plasma concentrations of the major component were 46.6 and 30.6 ng/mL at approximately 4 hours. A 12 mg amount is reached by taking multiple 3 mg tablets under a prescriber's direction, not by buying a 12 mg tablet in the United States.

What the label says the tablet is for: strongyloidiasis of the intestinal tract

The first approved indication is intestinal (that is, nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. The DOSAGE AND ADMINISTRATION section sets the recommended dose as a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight — micrograms, not milligrams — and the label states that additional doses are generally not necessary.

Table 1 of the label converts that into whole 3 mg tablets: 15–24 kg, 1 tablet; 25–35 kg, 2 tablets; 36–50 kg, 3 tablets; 51–65 kg, 4 tablets; 66–79 kg, 5 tablets; 80 kg and over, 200 mcg/kg. Two label instructions travel with it. Tablets should be taken on an empty stomach with water — a 30 mg dose after a high-fat meal produced an approximate 2.5-fold increase in bioavailability relative to the fasted state. And under Pediatric Use, safety and effectiveness in patients weighing less than 15 kg have not been established, which is why both dosing tables start at 15 kg. The PRECAUTIONS section states that ivermectin should not be used during pregnancy since safety in pregnancy has not been established.

What the label says about onchocerciasis, including the Mazzotti reaction

The second indication is onchocerciasis. The label is explicit about what the drug does not do: "STROMECTOL has no activity against adult Onchocerca volvulus parasites," which reside in subcutaneous nodules. Activity is against the tissue microfilariae, which is why treatment is repeated rather than curative.

The onchocerciasis dose is different from the strongyloidiasis dose: a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight. Table 2 runs 15–25 kg, 1 tablet; 26–44 kg, 2 tablets; 45–64 kg, 3 tablets; 65–84 kg, 4 tablets; 85 kg and over, 150 mcg/kg. The two tables do not share bands and should not be mixed.

Mazzotti reaction and the Loa loa warning

The WARNINGS section explains that microfilaricidal drugs as a class — its example is diethylcarbamazine citrate — might cause cutaneous and/or systemic reactions of varying severity, the Mazzotti reaction, along with ophthalmological reactions in patients with onchocerciasis, reactions the label attributes to allergic and inflammatory responses. Separately, PRECAUTIONS states that patients with onchocerciasis who are also heavily infected with Loa loa may rarely develop a serious or even fatal encephalopathy, either spontaneously or following treatment with an effective microfilaricide. The same WARNINGS section reports neurotoxicity — altered consciousness of variable severity, confusion, disorientation and death — including in patients without onchocerciasis.

Reading a package insert: which section answers which question

The STROMECTOL insert uses the older un-numbered format; the SOOLANTRA cream label uses numbered sections such as "1 INDICATIONS AND USAGE" and "12.1 Mechanism of Action." Either way, the question-to-section map is stable.

Your question Section of the ivermectin package insert What the STROMECTOL label says there
What is it approved for? INDICATIONS AND USAGE Two infections only: intestinal strongyloidiasis; onchocerciasis
How much, and how? DOSAGE AND ADMINISTRATION 200 mcg/kg (Table 1) or 150 mcg/kg (Table 2); empty stomach with water
Who must not take it? CONTRAINDICATIONS One sentence: hypersensitivity to any component of the product
What are the serious risks? WARNINGS / PRECAUTIONS Neurotoxicity; Mazzotti-type reactions; Loa loa encephalopathy; pregnancy; under 15 kg not established
What interacts with it? Drug Interactions One entry: rarely reported increased INR with warfarin
How does it behave in the body? CLINICAL PHARMACOLOGY Plasma half-life approximately 18 hours; primarily metabolized by CYP3A4; glutamate-gated chloride channel binding in invertebrates
What does the pack contain? HOW SUPPLIED NDC 0006-0032-20 and 0006-0032-01, unit dose packages of 20
How old is this text? Revision line at the end "Revised: 09/2024"

What is not an approved human product: injectables, capsules, powders, supplements

No ivermectin injection, capsule, powder, oral liquid or ophthalmic product is FDA-approved for human use. The approved human list stops at tablet, cream and lotion. Anything else marketed for people to swallow, inject or apply is outside the approved set.

Animal formulations

Ivermectin has a large approved veterinary footprint — FDA's Green Book active-ingredient report, generated 28 September 2026, lists 46 distinct approved animal drug applications with ivermectin as an active ingredient. These products are labeled for animal use only and are not approved for people. Examples: 21 CFR 520.1192 codifies ivermectin paste at 1.87 percent and 0.153 percent, with a horse dose of 200 micrograms per kilogram (91 micrograms per pound); the Farnam ivermectin paste label (ANADA 200-390) reads "For Oral Use in Horses Only" and states the syringe will treat up to 1250 lb of body weight. Dose, excipients and concentration in those products are built for the labeled species, and FDA's April 2020 letter to stakeholders states plainly: "People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled."

Supplements and unapproved listings

Ivermectin is a drug, not a permitted supplement ingredient, and it is not an OTC monograph active either. The pediculicide monograph at 21 CFR 358.610 permits only pyrethrum extract combined with piperonyl butoxide. Despite that, DailyMed carries ivermectin 0.5% topical listings filed as OTC monograph drugs rather than under any approved application — for example a lice lotion listing citing monograph M031, an ingredient category that does not include ivermectin. A listing in FDA's database is not an FDA approval. FDA has also treated online sales of ivermectin for COVID-19 as the introduction of misbranded and unapproved new drugs, in a warning letter dated 16 March 2023. On its consumer page "Ivermectin and COVID-19", content current as of 5 April 2024, FDA states it has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals, and advises that a prescription be filled "through a legitimate source such as a pharmacy." That page also acknowledges that, with few exceptions, health care professionals may prescribe an approved human drug for an unapproved use when they judge it medically appropriate for an individual patient. For how the approved products move through the supply chain, see where these are dispensed.

Where to see each label yourself, in one click

One caution if you use FDA's public API rather than the Orange Book: an openFDA Drugs@FDA query filtered by generic name, run on 28 September 2026, returned 13 ivermectin applications — two fewer than the Orange Book's 15. The product file is the count to trust.

How this page is maintained and dated

Every count on this page comes from the Orange Book product file dated 11 September 2026, with the online Orange Book stating currency through September 2026. Application-level details were re-checked against Drugs@FDA on 28 September 2026. Label quotations come from the current DailyMed SPLs: STROMECTOL revised 09/2024 (SPL updated 20 September 2024), SOOLANTRA updated 24 October 2024, SKLICE updated 11 July 2024. We record the label edition because label text changes between revisions, and a sentence quoted from a 2024 revision is not automatically the sentence on a 2027 revision.

We re-check three things on a fixed cycle: the Orange Book product file for new or withdrawn applications, the DailyMed revision dates for each product family, and FDA's consumer and enforcement pages. Where a figure could not be verified from a primary source — retail or cash prices, for instance — we leave it out rather than borrow a number from a secondary compilation.

Frequently asked questions

Is there an FDA-approved 12 mg ivermectin tablet in the US?

Not in the Orange Book product file dated 11 September 2026. The only listed tablet strengths are 3 mg and 6 mg. The 12 mg figure that circulates online is an amount some dosing schemes arrive at by combining 3 mg tablets, and it also appears on the STROMECTOL label as a pharmacokinetic study dose — not as a product you can be dispensed as a single tablet in the United States.

What are the brand name and the generic name?

The generic name is ivermectin. The brand tablet is STROMECTOL (NDA 050742, Merck Sharp & Dohme). Generic tablets are labeled "Ivermectin Tablets USP." The two branded topicals are SOOLANTRA cream 1% for inflammatory lesions of rosacea and SKLICE lotion 0.5% for head lice.

Can I buy ivermectin tablets over the counter?

Not under federal law: all 9 active ivermectin tablet rows in the Orange Book are prescription, and the only human ivermectin products with OTC marketing status are the 0.5% lotions for head lice. Separately, seven states have enacted access laws that are in force according to our state tracker: Arkansas (SB 189, Ark. Code Ann. § 20-7-147; commencement date not established in our dataset), Idaho (S 1211, in force 14 April 2025), Iowa (HF 2676, 1 July 2026), Louisiana (Act 464, 20 June 2025), Missouri (§ 338.208, 28 August 2026), Tennessee (Public Chapter 908, 22 April 2022) and Texas (HB 25, 4 December 2025). These statutes differ sharply: in Arkansas and Idaho nobody stands between the patient and the counter, while the other five — Iowa, Louisiana, Missouri, Tennessee and Texas — route the purchase through a pharmacist or a pharmacy, and none of them changes the federal Orange Book status of the tablet. North Dakota is often counted as an eighth access state, but its law is a shield, not an access law: N.D.C.C. § 43-15-42.4 (HB 1514, in force 15 November 2021) protects the prescriber or pharmacist from discipline or liability and creates no new route for a patient — a prescription is still required.

Is horse paste the same drug as an ivermectin tablet?

The active ingredient is the same molecule, but the products are not interchangeable. Equine paste is approved as an animal drug, labeled for animal use only and not approved for people; the Farnam label states it is for oral use in horses only and that one syringe treats up to 1250 lb of body weight. Human tablets are approved at 3 mg and 6 mg with human excipients, human dosing tables and a human safety section.

Do any US ivermectin labels cover scabies or COVID-19?

No US human ivermectin label carries an approved indication for scabies; the approved sets are strongyloidiasis and onchocerciasis (tablets), inflammatory lesions of rosacea (1% cream) and head lice (0.5% lotion). On COVID-19, FDA's consumer page, content current as of 5 April 2024, states it has not authorized or approved ivermectin for preventing or treating COVID-19 in humans or animals.

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