Prescription medicine
Alclometasone First approved as Aclovate
Alclometasone (Aclovate) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $0.533 per gram (Alclometasone dipr 0.05% ointment) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the alclometasone FDA label on DailyMed (effective April 5, 2021, Glenmark Pharmaceuticals Inc., USA); the NDA 18707 record on Drugs@FDA; every alclometasone label on DailyMed.
Highlights of the record
FDA label of April 5, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAlclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Forms and strengths
- 0.5 mg/g
Ointment; cream.
On the market
- Earliest approval on file
- December 14, 1982 Aclovate, Fougera; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first July 29, 2004; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.533 per gram Alclometasone dipr 0.05% ointment
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 309 through July 30, 2026
What is alclometasone used for?
From the label: indications and usageAlclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Alclometasone Dipropionate), Glenmark Pharmaceuticals Inc., USA, effective April 5, 2021 (SPL set 63e635e0-65d8-4b30-9f2a-ab16deba90bd), via openFDA; the full label on DailyMed
Is there a generic for alclometasone (Aclovate)?
The FDA approved the first generic alclometasone on July 29, 2004. 6 generic applications are approved; 4 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 alclometasone from 2 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.
- 1982 earliest approval on file
- 2004 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alclometasone (Aclovate)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.533 per gram (Alclometasone dipr 0.05% ointment), up 8% from $0.496 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.
- Alclometasone dipr 0.05% ointment (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alclometasone dipr 0.05% ointment | Generic | $0.533 per gram | n/a | +8% |
| Alclometasone dipro 0.05% cream | Generic | $1.57 per gram | n/a | +174% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for alclometasone?
The FDA Adverse Event Reporting System holds 309 reports that list alclometasone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 73 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.
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
- Alclometasone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other