Home NDC 36800-049 Athletes Foot
Product NDC 36800-049
11-digit product format 368000049
Labeler code 36800
Product ID 36800-049_39068ae7-6070-8978-e063-6294a90afd38
Type HUMAN OTC DRUG
Nonproprietary name Butenafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler TOPCO ASSOCIATES LLC
Application ANDA205181
Marketing category ANDA
Marketing start 2017-11-17
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 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 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.
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 2026-08-01 22:54:32 2026-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 18 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Athletes Foot
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-049-01 Athletes Foot 12 g in 1 TUBE CREAM 12 3 36800-049-01 Athletes Foot 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-049 ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 2 Current NDC, Legacy NDC, 2 package rows 20180821_3e976ed8-2af8-4d1e-bda6-e2f672c7ec03.zip
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 36800-049-01 36800004901 1 TUBE in 1 CARTON (36800-049-01) / 12 g in 1 TUBE 1 tube 2017-12-12 0000-00-00 No No Current