Quick answers
- What is Fluocinonide used for?
- The FDA-approved label (Fluocinonide, Bryant Ranch Prepack, June 1, 2026) says: “Fluocinonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluocinonide have a boxed warning?
- The label we quote has no boxed warning, but 2 of 47 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Fluocinonide?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated October 2, 2026). Ask your pharmacist about alternatives.
- Has Fluocinonide been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started March 25, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fluocinonide?
- 22 companies list prescription products of Fluocinonide in the FDA NDC Directory, including Bryant Ranch Prepack, Sun Pharmaceutical Industries, Inc. and NuCare Pharmaceuticals, Inc..
What Fluocinonide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fluocinonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
— FDA label: Fluocinonide, Bryant Ranch Prepack, effective June 1, 2026. Read the full label on DailyMed →
The FDA has 47 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.
2 of 47 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Solution · Ointment · Gel |
|---|---|
| Route | Topical |
| Prescription products | 52 in the FDA NDC Directory |
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 |
|---|---|---|
| fluocinonide 0.005% ointment | Generic | $0.2499–$0.3754 per gram 3 packages, lowest to highest |
| fluocinonide 0.05% cream | Generic | $0.2144–$0.8548 per gram 27 packages, lowest to highest |
| fluocinonide 0.05% gel | Generic | $0.5789–$1.02 per gram 6 packages, lowest to highest |
| fluocinonide 0.05% ointment | Generic | $0.2499–$0.3754 per gram 6 packages, lowest to highest |
| fluocinonide 0.1% cream | Generic | $0.2543–$0.3448 per gram 6 packages, lowest to highest |
| fluocinonide 0.5 mg/mL solution | Generic | $0.2117–$0.3152 per mL 11 packages, lowest to highest |
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 Prepack12 products
- Sun Pharmaceutical Industries, Inc.6 products
- NuCare Pharmaceuticals, Inc.5 products
- A-S Medication Solutions4 products
- Teva Pharmaceuticals USA, Inc.3 products
- Encube Ethicals, Inc.2 products
- Asclemed USA, Inc.2 products
- Zydus Lifesciences Limited2 products
- Cosette Pharmaceuticals, Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Xiromed, LLC1 product
- Saptalis Pharmaceuticals, LLC.1 product
- NorthStar RxLLC1 product
- Macleods Pharmaceuticals Limited1 product
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC1 product
- Padagis Israel Pharmaceuticals Ltd1 product
- Amneal Pharmaceuticals NY LLC1 product
- Novel Laboratories, Inc.1 product
- Quagen Pharmaceuticals LLC1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
- Viona Pharmaceuticals Inc1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (24)
- ANDA071500Sun Pharma Canada · June 10, 1987
- ANDA072494Taro · January 19, 1989
- ANDA072488Teva · February 6, 1989
- ANDA072490Teva · February 7, 1989
- ANDA073481Teva · December 27, 1991
- ANDA073085Cosette Pharms Nc · February 14, 1992
- ANDA072934Fougera Pharms Inc · February 27, 1995
- ANDA074204Cosette Pharms Nc · June 13, 1995
- ANDA074799Sun Pharma Canada · December 31, 1996
- ANDA074935Sun Pharma Canada · July 29, 1997
- ANDA075008Sun Pharma Canada · June 30, 1999
- ANDA200734Sun Pharma Canada · July 14, 2014
- ANDA206003Novel Labs Inc · July 21, 2017
- ANDA209283Macleods Pharms · April 23, 2018
- ANDA211111Amneal · June 4, 2018
- ANDA209030Padagis Us · June 19, 2018
- ANDA208948Zydus Pharms · July 17, 2018
- ANDA210554Amneal · August 21, 2018
- ANDA211410Encube · October 16, 2018
- ANDA209699Encube Ethicals · November 29, 2018
- ANDA207554Sciegen Pharms · March 18, 2019
- ANDA212976Xiromed · November 26, 2019
- ANDA208989Zydus Lifesciences · February 10, 2020
- ANDA216389Quagen · February 26, 2025
Shortage status
To be discontinued · updated October 2, 2026 · first posted October 2, 2026
| Product | Fluocinonide, Ointment, .5 mg/1 g (NDC 0093-0264-92) |
|---|---|
| Company | Teva Pharmaceuticals USA, 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 25, 2026 · Class II · Ongoing · D-0475-2026
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1 — SUN PHARMACEUTICAL INDUSTRIES INC
-
March 25, 2026 · Class II · Ongoing · D-0476-2026
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2. — SUN PHARMACEUTICAL INDUSTRIES INC
-
March 25, 2026 · Class II · Ongoing · D-0477-2026
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3. — SUN PHARMACEUTICAL INDUSTRIES INC
-
September 20, 2017 · Class III · Terminated · D-0146-2018
Cross contamination with other products: traces of Dapsone were found in the finished product.
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1 — Taro Pharmaceuticals U.S.A., Inc.
-
March 17, 2017 · Class III · Terminated · D-0790-2017
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1 — 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) — Fluocinonide, Bryant Ranch Prepack, effective June 1, 2026; 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 →