Home NDC 36800-080-01 Athletes Foot
Product NDC 36800-080
Requested package NDC 36800-080-01
11-digit product format 368000080
Labeler code 36800
Product ID 36800-080_a7a50c80-4e9a-41b0-ab6d-44c03ed2449d
Type HUMAN OTC DRUG
Nonproprietary name Terbinafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Topco Associates LLC
Application ANDA077511
Marketing category ANDA
Marketing start 2007-07-02
Marketing end 0000-00-00
Substance TERBINAFINE HYDROCHLORIDE
Active strength 1 g/100g
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-080 36800-080-01 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 36800-080 36800-080-01 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-080-01 Athletes Foot 1 in 1 CARTON CREAM 1 2 36800-080-01 Athletes Foot 15 g in 1 TUBE CREAM 15 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-080 ATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 2 Legacy NDC, 2 package rows 20190315_5019361d-e6af-4c3d-a246-a43358ae914c.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 36800-080-01 36800008001 1 TUBE in 1 CARTON (36800-080-01) > 15 g in 1 TUBE 1 tube 2007-07-02 0000-00-00 No No Current