Prescription medicine
Imiquimod Brand names: Zyclara; first approved as Aldara
Imiquimod (Aldara) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.610 per packet (Imiquimod 5% cream packet) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the imiquimod FDA label on DailyMed (effective May 23, 2025, Bausch Health US, LLC); the NDA 20723 record on Drugs@FDA; every imiquimod label on DailyMed.
Highlights of the record
FDA label of May 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZYCLARA 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.
Forms and strengths
- 2.5 mg/g
- 12.5 mg/.25g
- 37.5 mg/g
- 50 mg/g
Cream.
On the market
- Earliest approval on file
- February 27, 1997 Aldara, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first February 25, 2010; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 6 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 30, 2030 Zyclara cream; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.610 per packet Imiquimod 5% cream packet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,292 through July 30, 2026
What is imiquimod used for?
From the label: indications and usageZYCLARA 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. ( 1.1 )
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. […]
Source: FDA drug label (Zyclara), Bausch Health US, LLC, effective May 23, 2025 (SPL set 28cd9b5b-680b-480f-b33d-9c5b52bbf03d), via openFDA; the full label on DailyMed
What does the patient leaflet for imiquimod say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using ZYCLARA Cream?Do not cover the treated area with bandages or other closed dressings. Cotton gauze dressings can be used, if needed. Cotton underwear can be worn after applying ZYCLARA Cream to the genital or perianal area. • Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with ZYCLARA Cream. Use sunscreen and wear protective clothing if you go outside during daylight. • Do not have sexual contact including genital, anal, or oral sex when ZYCLARA Cream is on your genital or perianal skin. ZYCLARA Cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy. • Avoid using ZYCLARA Cream and any other imiquimod products in the same treatment area. They have the same active ingredients (imiquimod) and may increase your risk for side effects.
From the patient leaflet: How should I store ZYCLARA Cream?Store ZYCLARA Cream at room temperature between 68°F to 77°F (20°C to 25°C). • Store ZYCLARA Cream pumps upright. • Do not freeze. • Safely throw away ZYCLARA Cream that is out of date, unused or partially used. Keep ZYCLARA Cream and all medicines out of the reach of children.
Source: FDA drug label (Zyclara), Bausch Health US, LLC, effective May 23, 2025 (SPL set 28cd9b5b-680b-480f-b33d-9c5b52bbf03d), via openFDA; the full label on DailyMed
Is there a generic for imiquimod (Aldara)?
The FDA approved the first generic imiquimod on February 25, 2010. 9 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists imiquimod from 6 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Aldara cream; a patent listed only for Zyclara cream runs to April 30, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1997 earliest approval on file
- 2010 first generic approved
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for imiquimod (Aldara)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.610 per packet (Imiquimod 5% cream packet), down 22% from $0.782 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Imiquimod 5% cream packet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Imiquimod 3.75% cream | Generic | $36.23 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +64% |
| Imiquimod 3.75% cream pump | Generic | $113.12 per gram | n/a | +364% |
| Imiquimod 5% cream packet | Generic | $0.610 per packet | n/a | -22% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for imiquimod?
The FDA Adverse Event Reporting System holds 2,292 reports that list imiquimod among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 73 are coded as a death and 322 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Imiquimod side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other