Home NDC 50066-080 Silka
Product NDC 50066-080
11-digit product format 500660080
Labeler code 50066
Product ID 50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a
Type HUMAN OTC DRUG
Nonproprietary name Terbinafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Genomma Lab USA, Inc.
Application ANDA077511
Marketing category ANDA
Marketing start 2007-07-02
Substance TERBINAFINE HYDROCHLORIDE
Active strength 1 g/100g
Pharmacologic classes Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077511-001 TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Silka
Brand name suffix Antifungal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBINAFINE HYDROCHLORIDE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 012C11ZU6G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992528 Internal RxNorm lookup 1739221 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50066-080-02 Silka Antifungal 30 g in 1 TUBE CREAM 30 7 50066-080-02 Silka Antifungal 1 in 1 CARTON CREAM 1 7 50066-080-03 Silka Antifungal 30 g in 1 TUBE CREAM 30 7 50066-080-03 Silka Antifungal 1 in 1 CARTON CREAM 1 7 50066-080-05 Silka Antifungal 15 g in 1 TUBE CREAM 15 7 50066-080-05 Silka Antifungal 1 in 1 CARTON CREAM 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Terbinafine Hydrochloride ACTIVE INGREDIENT 012C11ZU6G SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 Terbinafine ACTIVE MOIETY G7RIW8S0XP SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 cetyl palmitate INACTIVE INGREDIENT 5ZA2S6B08X SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50066-080 SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.] 6 Current NDC, Legacy NDC, 6 package rows 20240412_a32cf699-e63e-4bd3-a5af-9e1ba447e02e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50066-080-02 50066008002 1 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBE 1 tube 2007-07-02 0000-00-00 No No Current 50066-080-03 50066008003 1 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBE 1 tube 2018-05-21 0000-00-00 No No Current 50066-080-05 50066008005 1 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBE 1 tube 2018-12-20 0000-00-00 No No Current