Prescription medicine
Fluocinonide First approved as Lidex
Fluocinonide (Lidex) is a prescription medicine with an FDA approval on record since 1971. FDA's NDC Directory lists it from 25 generic labelers, and pharmacies paid $0.243 per gram (Fluocinonide 0.05% cream) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the fluocinonide FDA label on DailyMed (effective September 30, 2024, Teva Pharmaceuticals USA, Inc.); the NDA 16908 record on Drugs@FDA; every fluocinonide label on DailyMed.
Highlights of the record
FDA label of September 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageThe topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Forms and strengths
- 0.05 mg/g
- 0.5 mg/g
- 0.5 mg/ml
- 1 mg/g
Cream; solution; ointment; gel.
On the market
- Earliest approval on file
- June 30, 1971 Lidex, Alvogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 40 first June 10, 1987; 30 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 25 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.243 per gram Fluocinonide 0.05% cream
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 8 since 2014 0 Class I among all firms' recalls; latest March 25, 2026
- FAERS reports
- 5,594 through July 30, 2026
What is fluocinonide used for?
From the label: indications and usageThe topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Fluocinonide), Teva Pharmaceuticals USA, Inc., effective September 30, 2024 (SPL set 986c1ba3-2103-4773-a35c-2c0121a01783), via openFDA; the full label on DailyMed
Is there a generic for fluocinonide (Lidex)?
The FDA approved the first generic fluocinonide on June 10, 1987. 40 generic applications are approved; 30 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 fluocinonide from 25 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1971 earliest approval on file
- 1987 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluocinonide (Lidex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.243 per gram (Fluocinonide 0.05% cream), down 30% from $0.345 on October 8, 2025. 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.
- Fluocinonide 0.05% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluocinonide 0.05% cream | Generic | $0.243 per gram | n/a | -30% |
| Fluocinonide 0.05% gel | Generic | $1.02 per gram | n/a | -4% |
| Fluocinonide 0.05% ointment | Generic | $0.256 per gram | n/a | -17% |
| Fluocinonide 0.05% solution | Generic | $0.205 per mL | n/a | -3% |
| Fluocinonide 0.1% cream | Generic | $0.254 per gram | n/a | -0.7% |
| Fluocinonide-e 0.05% cream | Generic | $0.767 per gram | n/a | -25% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is fluocinonide in shortage?
No fluocinonide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated October 2, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Fluocinonide, Ointment, .5 mg/1 g (NDC 0093-0264-15) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | October 2, 2026 |
| Fluocinonide, Ointment, .5 mg/1 g (NDC 0093-0264-30) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | October 2, 2026 |
| Fluocinonide, Ointment, .5 mg/1 g (NDC 0093-0264-92) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | October 2, 2026 |
Every fluocinonide presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has fluocinonide been recalled?
The FDA's Enforcement Report lists 8 recalls naming fluocinonide since 2014: 0 Class I (the most serious), 6 Class II, 2 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 25, 2026 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. |
| March 15, 2022 | Class II | Teligent Pharma, Inc. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| September 20, 2017 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Cross contamination with other products: traces of Dapsone were found in the finished product. |
| March 17, 2017 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate. |
| August 28, 2014 | Class II | Fougera Pharmaceuticals Inc. | Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for fluocinonide?
The FDA Adverse Event Reporting System holds 5,594 reports that list fluocinonide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 259 are coded as a death and 1,021 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?
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Fluocinonide side effects
- the label's list beside FAERS reports
- Fluocinonide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other