Prescription medicine
Clocortolone pivalate First approved as Cloderm
Clocortolone pivalate (Cloderm) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the clocortolone pivalate FDA label on DailyMed (effective July 14, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 17765 record on Drugs@FDA; every clocortolone pivalate label on DailyMed.
Highlights of the record
FDA label of July 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTopical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Forms and strengths
- 0.001 g/g
Cream.
On the market
- Earliest approval on file
- August 22, 1977 Cloderm, Legacy; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first April 21, 2020; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2018 0 Class I among all firms' recalls; latest March 8, 2018
- FAERS reports
- 26 through July 30, 2026
What is clocortolone pivalate used for?
From the label: indications and usageTopical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Clocortolone Pivalate), ANDA206370 (Taro), as published by Sun Pharmaceutical Industries, Inc., effective July 14, 2026 (SPL set 88d9a7cf-31b5-4b85-9827-0ecce328e6a0), via openFDA; the full label on DailyMed
Is there a generic for clocortolone pivalate (Cloderm)?
The FDA approved the first generic clocortolone pivalate on April 21, 2020. 1 generic application is approved; 1 of it carries 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 clocortolone pivalate from 1 labeler 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.
- 1977 earliest approval on file
- 2020 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has clocortolone pivalate been recalled?
The FDA's Enforcement Report lists 1 recall naming clocortolone pivalate since 2018: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 8, 2018 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for clocortolone pivalate?
The FDA Adverse Event Reporting System holds 26 reports that list clocortolone pivalate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 1 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
- Clocortolone pivalate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other