Quick answers
- What is Pramosone?
- Pramosone is a brand name of Hydrocortisone acetate and pramoxine hydrochloride, a prescription medicine. The FDA NDC Directory lists 3 Pramosone products in 2 strengths and forms.
- Who makes Pramosone?
- Legacy holds the FDA application for Pramosone (ANDA085979, approved June 5, 1978). 1 other company (repackagers or distributors) also list Pramosone products.
- Is there a generic or store brand of Pramosone?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Pramosone product, 2 of them generic. Ask your pharmacist whether one is right for you.
- Has Pramosone been recalled?
- No recall linked to Pramosone products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Pramosone is
Each Pramosone 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 10 mg/mL · pramoxine hydrochloride 10 mg/mL lotion (topical) | Pramosone | None listed | DailyMed |
| hydrocortisone acetate 25 mg/mL · pramoxine hydrochloride 10 mg/mL lotion (topical) | Pramosone | 2 products, 2 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 |
|---|---|---|---|
| ANDA085979 | Legacy | June 5, 1978 | 1 |
| ANDA085980 | Legacy | June 5, 1978 | 2 |
Companies that list Pramosone
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Pramosone products.
- Legacy Pharma USA Inc.2 products
- Sebela Pharmaceuticals Inc.1 product
Recalls
No recall linked to Pramosone 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.