Active ingredient
Naftifine
5 finished FDA listings contain Naftifine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NAFTIFINE HYDROCHLORIDE
- Dosage forms
- Cream, Gel
- Routes
- Topical
- Manufacturers / labelers
- 3
- Strengths listed
- 10 mg/g · 2 g/100g · 20 mg/g
- Brand names in FDA listings
- Naftin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 31476
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 204286 | LEGACY | 2013-06-27 | 2 |
| ANDA 206901 | SUN PHARMA CANADA | 2016-01-06 | 1 |
| ANDA 205975 | SUN PHARMA CANADA | 2016-09-08 | 1 |
| ANDA 208201 | SUN PHARMA CANADA | 2019-04-10 | 1 |
Official labeling on DailyMed
- NAFTIFINE HYDROCHLORIDE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 11 · 2026-02-16
- NAFTIFINE HYDROCHLORIDE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 7 · 2025-11-18
- NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [SEBELA PHARMACEUTICALS INC.] · version 7 · 2025-11-17
- NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [LEGACY PHARMA USA INC.] · version 1 · 2025-08-01
- NAFTIFINE HYDROCHLORIDE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 3 · 2025-07-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.