Home NDC 79481-0086 Butenafine Hydrochloride
Product NDC 79481-0086
11-digit product format 794810086
Labeler code 79481
Product ID 79481-0086_39070e62-eb92-10ca-e063-6394a90a7564
Type HUMAN OTC DRUG
Nonproprietary name Butenafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler MEIJER DISTRIBUTION INC
Application ANDA205181
Marketing category ANDA
Marketing start 2023-11-30
Substance BUTENAFINE HYDROCHLORIDE
Active strength 10 mg/g
Pharmacologic classes Benzylamine Antifungal [EPC], Benzylamines [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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 79481-0086-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 79481-0086-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 79481-0086-1 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A205181-001 BUTENAFINE HYDROCHLORIDE BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16
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 · 42 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 2026-08-18 06:07:40 2026-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Butenafine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTENAFINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R8XA2029ZI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1298448 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79481-0086-1 Butenafine Hydrochloride 1 in 1 CARTON CREAM 1 5 79481-0086-1 Butenafine Hydrochloride 30 g in 1 TUBE CREAM 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79481-0086 BUTENAFINE HYDROCHLORIDE CREAM [MEIJER DISTRIBUTION INC] 4 Current NDC, 2 package rows 20250213_4e88068b-1449-43b4-9c7c-4ad8e877459b.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 1 · 18 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 79481-0086-1 79481008601 1 TUBE in 1 CARTON (79481-0086-1) / 30 g in 1 TUBE 1 tube 2023-11-30 No No Current