Home NDC 59779-523-01 CVS
Product NDC 59779-523
Requested package NDC 59779-523-01
11-digit product format 597790523
Labeler code 59779
Product ID 59779-523_446e5c7a-48c9-cef4-e063-6294a90a6d32
Type HUMAN OTC DRUG
Nonproprietary name Terbinafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler CVS Pharmacy
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077511-001 TERBINAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2007-07-02 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base CVS
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 · 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# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-11-25 CVS 2025-07-29 CVS 2024-04-30 CVS 2023-01-30 CVS 2021-06-18 CVS 2020-01-31 CVS
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59779-523-01 CVS 1 in 1 CARTON CREAM 1 4 59779-523-01 CVS 15 g in 1 TUBE CREAM 15 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59779-523 CVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY] 3 Current NDC, Legacy NDC, 2 package rows 20240502_17684ba2-3c2c-4259-84fa-3833f19e5a4d.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 1 of 2 · 24 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 59779-523-01 59779052301 1 TUBE in 1 CARTON (59779-523-01) / 15 g in 1 TUBE 1 tube 2008-12-09 0000-00-00 No No Current