Active ingredient
Terbinafine
76 finished FDA listings contain Terbinafine as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TERBINAFINE, TERBINAFINE HYDROCHLORIDE
- Dosage forms
- Cream, Liquid, Spray, Tablet
- Routes
- Oral, Topical
- Manufacturers / labelers
- 46
- Strengths listed
- .01 g/ml · 1 g/100g · 250 1/1 · 250 mg/1
- Brand names in FDA listings
- Antifungal, Athlete Foot Cream, Athletes Foot, Curist Antifungal Relief, Cvs, Cvs Pharmacy Athletes Foot, Equate Athletes Foot, Good Neighbor Pharmacy, Kroger Antifungal, Lamisil At, Lamisil At Cream, Lamisil At Terbinafine Hydrochloride, Pharmbanner Tinea Versicolor Cream, Silka Antifungal, Silka Jock Itch, Terbinafine, Terbinafine Hydrochloride, Toenail Fungus Treatment, Walgreens Athletes Foot
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 37801
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 020980 | KARO HLTHCARE | 1999-03-09 | 5 |
| NDA 021124 | KARO HLTHCARE | 2000-03-17 | 2 |
| ANDA 077533 | INVAGEN PHARMS | 2007-07-02 | 5 |
| ANDA 078163 | ORBION PHARMS | 2007-07-02 | 5 |
| ANDA 076390 | SENORES PHARMS | 2007-07-02 | 4 |
| ANDA 077137 | CIPLA | 2007-07-02 | 3 |
| ANDA 078199 | CHARTWELL | 2007-07-02 | 1 |
| ANDA 078297 | AUROBINDO PHARMA | 2007-07-02 | 14 |
| ANDA 077511 | SUN PHARMA CANADA | 2007-07-02 | 24 |
| ANDA 077714 | BRECKENRIDGE PHARM | 2010-06-04 | 10 |
Official labeling on DailyMed
- TERBINAFINE (TERBINAFINE HYDROCHLORIDE TABLET) TABLET [AMERISYN LLC] · version 1 · 2026-08-07
- TERBINAFINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 7 · 2026-07-13
- ATHLETE FOOT CREAM (TERBINAFINE HYDROCHLORIDE) CREAM [BEAUTIVITY LLC] · version 3 · 2026-06-30
- TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2026-04-29
- TERBINAFINE HYDROCHLORIDE CREAM [SCHOLL'S WELLNESS COMPANY LLC] · version 4 · 2026-04-06
- TOENAIL FUNGUS TREATMENT (TERBINAFINE) LIQUID [SHENZHEN WANKELAI E-COMMERCE CO., LTD.] · version 1 · 2026-03-25
- TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [AMERICAN HEALTH PACKAGING] · version 1 · 2026-03-09
- TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [NUCARE PHARMACEUTICALS,INC.] · version 2 · 2026-03-09
- TERBINAFINE HYDROCHLORIDE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2026-02-23
- TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [AMICI PHARMA, INC.] · version 1 · 2026-02-23
- TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.] · version 5 · 2026-02-16
- PHARMBANNER TINEA VERSICOLOR CREAM (TINEA VERSICOLOR CREAM) CREAM [SHENZHEN XINXIN YUNHAI TECHNOLOGY CO., LTD.] · version 2 · 2026-02-16
Showing the 12 most recent of 74 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.