Home NDC 85398-006 Athlete Foot Cream
Product NDC 85398-006
11-digit product format 853980006
Labeler code 85398
Product ID 85398-006_5567002c-6358-9fe7-e063-6294a90ab509
Type HUMAN OTC DRUG
Nonproprietary name Terbinafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Beautivity LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-18
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 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 Athlete Foot Cream
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 85398-006-01 Athlete Foot Treatment Kit 60 g in 1 CARTON CREAM 60 g 1 g in 100g 2 85398-006-01 Athlete Foot Cream 60 g in 1 CARTON CREAM 60 2
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 8 of 49 · 973 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 85398-006-01 85398000601 60 g in 1 CARTON (85398-006-01) 60 g 2025-08-18 No No Current