Home NDC 85398-017 Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream
Product NDC 85398-017
11-digit product format 853980017
Labeler code 85398
Product ID 85398-017_5566e746-fd25-6a51-e063-6294a90a8c82
Type HUMAN OTC DRUG
Nonproprietary name tolnaftate 1%
Dosage form CREAM
Route TOPICAL
Labeler Beautivity LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-31
Substance TOLNAFTATE
Active strength .6 g/60g
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 Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE .6 g/60g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103951 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85398-017-01 Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream 60 g in 1 CARTON CREAM 60 3 85398-017-02 Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream 57 g in 1 TUBE CREAM 57 3 85398-017-02 Hermon Athletes foot Tolnaftate 1% kit 57 g in 1 TUBE CREAM 57 g 0.57 g in 57g 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 85398-017-01 85398001701 60 g in 1 CARTON (85398-017-01) 60 g 2025-10-31 No No Current 85398-017-02 85398001702 57 g in 1 TUBE (85398-017-02) 57 g 2025-10-31 No No Current