Quick answers
- What is Clocortolone pivalate used for?
- The FDA-approved label (Clocortolone Pivalate, Sun Pharmaceutical Industries, Inc., July 14, 2026) says: “Topical corticosteroids are 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 Clocortolone pivalate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Clocortolone pivalate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clocortolone pivalate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Clocortolone pivalate?
- 1 company lists prescription products of Clocortolone pivalate in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc..
What Clocortolone pivalate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
— FDA label: Clocortolone Pivalate, Sun Pharmaceutical Industries, Inc., effective July 14, 2026. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Cream |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
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.
- Sun Pharmaceutical Industries, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA206370Taro · April 21, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 197520 |
|---|---|
| SPL set ID of the quoted label | 88d9a7cf-31b5-4b85-9827-0ecce328e6a0 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | CLOCORTOLONE PIVALATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Clocortolone Pivalate, Sun Pharmaceutical Industries, Inc., effective July 14, 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 →