Quick answers
- What is Podofilox used for?
- The FDA-approved label (Condylox, Allergan, Inc., January 29, 2024) says: “Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Podofilox have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Podofilox?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated January 28, 2026). Ask your pharmacist about alternatives.
- Has Podofilox been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Podofilox?
- 2 companies list prescription products of Podofilox in the FDA NDC Directory, including Padagis US LLC and Allergan, Inc..
What Podofilox is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. …
— FDA label: Condylox, Allergan, Inc., effective January 29, 2024. Read the full label on DailyMed →
The FDA has 3 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.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Gel · Solution |
|---|---|
| Route | Topical |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Condylox |
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 |
|---|---|---|
| podofilox 0.5% gel | Generic | $132.91 per gram |
| podofilox 5 mg/mL solution | Generic | $15.15 per mL |
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.
- Padagis US LLC2 products
- Allergan, Inc.1 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 |
|---|---|---|---|
| NDA020529 CONDYLOX | Allergan | March 13, 1997 | 1, latest March 13, 1997 1997: UNKNOWN |
Generic approvals (2)
- ANDA075600Padagis Us · January 29, 2002
- ANDA211871Padagis Us · November 22, 2023
Shortage status
To be discontinued · updated January 28, 2026 · first posted January 28, 2026
| Product | Condylox , Topical Gel, 0.5% (NDC 0023-6118-03) |
|---|---|
| Company | AbbVie Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0549-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05. — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 312466, 351750, 582926 |
|---|---|
| SPL set ID of the quoted label | 032e4bcb-b1ed-4029-b2a6-e92f3bf5cc37 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA020529, 2 ANDA |
| Active ingredients (FDA) | PODOFILOX |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Condylox, Allergan, Inc., effective January 29, 2024; 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 →