Quick answers
- What is Pramosone Cream?
- Pramosone Cream is a brand name of Hydrocortisone acetate and pramoxine hydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Pramosone Cream products in 1 strength and form.
- Who makes Pramosone Cream?
- Legacy holds the FDA application for Pramosone Cream (ANDA085368, approved January 7, 1977).
- Is there a generic or store brand of Pramosone Cream?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Pramosone Cream product, 4 of them generic. Ask your pharmacist whether one is right for you.
- Has Pramosone Cream been recalled?
- No recall linked to Pramosone Cream products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Pramosone Cream is
Each Pramosone Cream product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Hydrocortisone acetate and pramoxine hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| hydrocortisone acetate 1% · pramoxine hydrochloride 1% cream (topical) | Pramosone Cream | 4 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Hydrocortisone acetate and pramoxine hydrochloride →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA085368 | Legacy | January 7, 1977 | 2 |
Companies that list Pramosone Cream
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Pramosone Cream products.
- Legacy Pharma USA Inc.2 products
Recalls
No recall linked to Pramosone Cream products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.