Home NDC 63187-111 Terbinafine Hydrochloride
Product NDC 63187-111
11-digit product format 631870111
Labeler code 63187
Product ID 63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992
Type HUMAN OTC DRUG
Nonproprietary name Terbinafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Proficient Rx LP
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 c2088c7a36db…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…
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 Terbinafine Hydrochloride
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992528 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 63187-111-15 Terbinafine Hydrochloride 15 g in 1 TUBE CREAM 15 6 63187-111-15 Terbinafine Hydrochloride 1 in 1 CARTON CREAM 1 6 63187-111-30 Terbinafine Hydrochloride 30 g in 1 TUBE CREAM 30 6 63187-111-30 Terbinafine Hydrochloride 1 in 1 CARTON CREAM 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-111 TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP] 6 Current NDC, Legacy NDC, 4 package rows 20220722_76f7525d-2005-4da8-a795-50ede6236c68.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 · 22 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 63187-111-15 63187011115 1 TUBE in 1 CARTON (63187-111-15) / 15 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current 63187-111-30 63187011130 1 TUBE in 1 CARTON (63187-111-30) / 30 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current