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Prescription medicine · generic available

Fluocinolone acetonide

Brand names: Fluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar, Yutiq, Flac Otic Oil, Dermotic, Iluvien

Drug class: Corticosteroid

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
14Recalls (FDA reports)
18Companies
1963First FDA approval on file

Quick answers

What is Fluocinolone acetonide used for?
The FDA-approved label (Synalar, Medimetriks Pharmaceuticals, Inc., July 18, 2024) says: “SYNALAR ® Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Fluocinolone acetonide have a boxed warning?
No. None of the 43 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Fluocinolone acetonide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Fluocinolone acetonide been recalled?
FDA enforcement reports list 14 recalls of products of this medicine; the newest started December 30, 2025 (Class III). A recall usually concerns specific lots, not every product.
Who makes Fluocinolone acetonide?
18 companies list prescription products of Fluocinolone acetonide in the FDA NDC Directory, including Bryant Ranch Prepack, ANI Pharmaceuticals, Inc. and Rising Pharma Holdings, Inc..

What Fluocinolone acetonide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

SYNALAR ® Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

— FDA label: Synalar, Medimetriks Pharmaceuticals, Inc., effective July 18, 2024. Read the full label on DailyMed →

The FDA has 43 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 43 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsOil · Solution · Cream · Ointment · Implant
RouteTopical · Auricular (otic) · Intravitreal
Prescription products46 in the FDA NDC Directory
Brand namesFluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar, Yutiq, Flac Otic Oil, Dermotic, Iluvien

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.

NADAC per unit for Fluocinolone acetonide, by strength and form
Strength and formGeneric or brandPharmacies pay
fluocinolone acetonide 0.01 mg/100 mL
oil		 Generic $0.1663–$0.1759 per mL
2 packages, lowest to highest
fluocinolone acetonide 0.01%
cream		 Generic $1.23–$1.59 per gram
4 packages, lowest to highest
fluocinolone acetonide 0.025%
cream		 Generic $1.03–$1.37 per gram
4 packages, lowest to highest
fluocinolone acetonide 0.025%
ointment		 Generic $0.5637–$1.33 per gram
6 packages, lowest to highest
fluocinolone acetonide 0.1 mg/mL
solution		 Generic $0.2267 per mL
fluocinolone acetonide 0.11 mg/118.28 mL
oil		 Generic $0.1663–$0.1759 per mL
2 packages, lowest to highest
fluocinolone acetonide 0.11 mg/mL
oil		 Generic $0.1663–$0.9066 per mL
7 packages, lowest to highest
fluocinolone acetonide 0.11 mg/mL
oil		 Brand: Derma-Smoothe/FS $0.2426 per mL
fluocinolone acetonide 0.11 mg/mL
oil		 Brand: Derma-Smoothe/Fs $0.2419 per mL
fluocinolone acetonide 0.11 mg/mL
oil		 Brand: Dermotic $1.13 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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA012787
SYNALAR		 EurofarmaFebruary 15, 1963 39, latest March 28, 2013
2013: Manufacturing (CMC) · 2000: Manufacturing (CMC) · 1996: Manufacturing (CMC)
NDA013960
SYNALAR		 EurofarmaJune 19, 1963 35, latest September 26, 2000
2000: Manufacturing (CMC) · 1995: Labeling · 1995: Labeling
NDA019452
DERMA-SMOOTHE/FS, DERMOTIC		 Hill DermacFebruary 3, 1988 23, latest August 30, 2024
2024: Labeling · 2020: Labeling · 2016: Manufacturing (CMC)
NDA201923
ILUVIEN		 Alimera Sciences IncSeptember 26, 2014 3, latest March 12, 2025
2025: Labeling · 2017: Labeling · 2015: Manufacturing (CMC)
NDA210331
YUTIQ		 Alimera Sciences IncOctober 12, 2018 —

Generic approvals (22)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. December 30, 2025 · Class III · Ongoing · D-0256-2026

    Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

    Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4 — SUN PHARMACEUTICAL INDUSTRIES INC

  2. November 4, 2021 · Class II · Terminated · D-0234-2022

    Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

    Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86 — Amneal Pharmaceuticals of New York, LLC

  3. May 21, 2021 · Class II · Terminated · D-0637-2021

    Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

    DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20 — Hill Dermaceuticals, Inc.

  4. January 15, 2019 · Class II · Terminated · D-0390-2019

    Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.

    Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-06 — LUPIN SOMERSET

  5. October 5, 2018 · Class II · Terminated · D-0092-2019

    Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis

    Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60 — LUPIN SOMERSET

  6. July 5, 2018 · Class II · Terminated · D-0909-2018

    Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.

    Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, N — Teva Pharmaceuticals USA

  7. April 13, 2018 · Class II · Terminated · D-0712-2018

    Subpotent Drug

    Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC — Lyne Laboratories, Inc.

  8. April 13, 2018 · Class II · Terminated · D-0711-2018

    Subpotent Drug

    Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 6498 — Lyne Laboratories, Inc.

  9. April 13, 2018 · Class II · Terminated · D-0713-2018

    Subpotent Drug

    Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 6498 — Lyne Laboratories, Inc.

  10. February 22, 2017 · Class III · Terminated · D-0653-2017

    Chemical Contamination

    Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, I — Novel Laboratories, Inc.

  11. January 31, 2014 · Class III · Terminated · D-1178-2014

    Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

    ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20 — Hill Dermaceuticals, Inc.

  12. January 31, 2014 · Class III · Terminated · D-1176-2014

    Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

    ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04 — Hill Dermaceuticals, Inc.

  13. January 31, 2014 · Class III · Terminated · D-1177-2014

    Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

    ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04 — Hill Dermaceuticals, Inc.

  14. September 30, 2013 · Class III · Terminated · D-391-2014

    Failed Content Uniformity Specifications; at the 18 month time point.

    G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 — G & W Laboratories 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)1191256, 1191260, 1191299, 1191301, 1191302, 1191307, 1191309, 1191310, 1191315, 1191319 … (+5)
SPL set ID of the quoted label5af2e4c1-082b-48a0-aae7-72d4a68cbb2d
FDA labels (SPL)43
FDA applicationsNDA012787, NDA013960, NDA019452, NDA201923, NDA210331, 22 ANDA
Active ingredients (FDA)FLUOCINOLONE ACETONIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Synalar, Medimetriks Pharmaceuticals, Inc., effective July 18, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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