Quick answers
- What is Fluorouracil used for?
- The FDA-approved label (Tolak, Hill Dermaceuticals, Inc., September 6, 2022) says: “Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. Tolak (fluorouracil) Cream, 4%, is a nucleoside metabolic inhibitor indicated for the topical treatment of actinic keratosis lesions of the face, ears, and scalp.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluorouracil have a boxed warning?
- The label we quote has no boxed warning, but 18 of 36 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Fluorouracil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluorouracil been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 28, 2019 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Fluorouracil?
- 22 companies list prescription products of Fluorouracil in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Gland Pharma Limited and Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
What Fluorouracil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. Tolak (fluorouracil) Cream, 4%, is a nucleoside metabolic inhibitor indicated for the topical treatment of actinic keratosis lesions of the face, ears, and scalp.
— FDA label: Tolak, Hill Dermaceuticals, Inc., effective September 6, 2022. Read the full label on DailyMed →
The FDA has 36 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.
18 of 36 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| fluorouracil 0.5% cream | Generic | $0.6474–$42.82 per gram 2 packages, lowest to highest |
| fluorouracil 2 g/40 g cream | Generic | $0.6474 per gram |
| fluorouracil 20 mg/mL solution | Generic | $3.38 per mL |
| fluorouracil 5% cream | Generic | $0.6474 per gram |
| fluorouracil 50 mg/mL solution | Generic | $4.29 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.
- Fresenius Kabi USA, LLC6 products
- Gland Pharma Limited4 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- BluePoint Laboratories4 products
- Eugia US LLC4 products
- Xiromed, LLC4 products
- Sun Pharmaceutical Industries, Inc.3 products
- Accord Healthcare Inc.3 products
- Alembic Pharmaceuticals Limited2 products
- Encube Ethicals, Inc.2 products
- Meitheal Pharmaceuticals Inc.2 products
- Alembic Pharmaceuticals Inc.2 products
- Avyxa Pharma, LLC2 products
- Dr. Reddy's Labratories Inc.1 product
- Hill Dermaceuticals, Inc.1 product
- Bausch Health US, LLC1 product
- Mylan Pharmaceuticals Inc.1 product
- ProPharma Distribution1 product
- NorthStar Rx LLC1 product
- Sagent Pharmaceuticals1 product
- Mayne Pharma Inc.1 product
- Dr. Reddy's Laboratories 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 |
|---|---|---|---|
| NDA016831 EFUDEX | Extrovis | July 29, 1970 | 45, latest October 14, 2021 2021: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA020985 CARAC | Extrovis | October 27, 2000 | 8, latest July 1, 2025 2025: Manufacturing (CMC) · 2022: Labeling · 2015: Manufacturing (CMC) |
| NDA022259 TOLAK | Hill Dermaceuticals | September 18, 2015 | 1, latest August 25, 2022 2022: Labeling |
| NDA220201 FAVLYXA | Avyxa Holdings | February 20, 2026 | — |
Generic approvals (19)
- ANDA040278Fresenius Kabi USA · September 30, 1998
- ANDA040279Fresenius Kabi USA · September 30, 1998
- ANDA076526Taro · November 5, 2003
- ANDA040743Accord Hlthcare · April 26, 2007
- ANDA040798Accord Hlthcare · April 26, 2007
- ANDA077524DR Reddys Labs SA · April 11, 2008
- ANDA090368Taro · March 5, 2010
- ANDA202668Eugia Pharma Speclts · July 17, 2012
- ANDA202669Eugia Pharma Speclts · July 17, 2012
- ANDA203609Sagent Pharms Inc · February 17, 2016
- ANDA210123Gland · October 27, 2017
- ANDA210124Gland · December 26, 2017
- ANDA214845Accord Hlthcare · October 7, 2021
- ANDA217295Alembic · March 3, 2023
- ANDA217676Alembic · October 18, 2023
- ANDA215612Encube · November 2, 2023
- ANDA216494Kindos · September 24, 2024
- ANDA215699Kindos · February 6, 2025
- ANDA216942Encube · February 12, 2025
Shortage status
The FDA drug shortage list does not show these products.
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.
-
June 28, 2019 · Class I · Terminated · D-1489-2019
Presence of Particulate Matter; glass particulates
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand] — Fresenius Kabi USA, LLC
-
November 21, 2012 · Class II · Terminated · D-086-2013
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6. — Taro Pharmaceuticals U.S.A., 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tolak, Hill Dermaceuticals, Inc., effective September 6, 2022; 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 →