Quick answers
- What is Imiquimod used for?
- The FDA-approved label (Zyclara, Bausch Health US, LLC, May 23, 2025) says: “• ZYCLARA 2.5% and 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. • ZYCLARA, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Imiquimod have a boxed warning?
- The label we quote has no boxed warning, but 1 of 10 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Imiquimod?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Imiquimod been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Imiquimod?
- 9 companies list prescription products of Imiquimod in the FDA NDC Directory, including Bryant Ranch Prepack, Bausch Health US, LLC and Sun Pharmaceutical Industries, Inc..
What Imiquimod is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
• ZYCLARA 2.5% and 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. • ZYCLARA, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. …
— FDA label: Zyclara, Bausch Health US, LLC, effective May 23, 2025. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream |
|---|---|
| Route | Topical |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Zyclara |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| imiquimod 12.5 mg/0.25 g cream | Generic | $0.5940–$12.44 per unit 2 packages, lowest to highest |
| imiquimod 3.75% cream | Generic | $36.36 per unit |
| imiquimod 3.75% cream | Generic | $113.70 per gram |
| imiquimod 5% cream | Generic | $0.5940 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack3 products
- Bausch Health US, LLC3 products
- Sun Pharmaceutical Industries, Inc.2 products
- Padagis Israel Pharmaceuticals Ltd1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Oceanside Pharmacueticals1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Direct_Rx1 product
- Anvi Pharmaceuticals Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022483 ZYCLARA | Bausch | March 25, 2010 | 6, latest September 16, 2024 2024: Labeling · 2014: Manufacturing (CMC) · 2012: Manufacturing (CMC) |
Generic approvals (4)
- ANDA078837Padagis Israel · September 7, 2010
- ANDA200173Taro · April 15, 2011
- ANDA201994Glenmark Pharms · March 6, 2012
- ANDA205971Taro · January 26, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 310982, 967017, 967021 |
|---|---|
| SPL set ID of the quoted label | 28cd9b5b-680b-480f-b33d-9c5b52bbf03d |
| FDA labels (SPL) | 10 |
| FDA applications | NDA022483, 4 ANDA |
| Active ingredients (FDA) | IMIQUIMOD |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zyclara, Bausch Health US, LLC, effective May 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →