Home NDC 54312-230 Derman Antifungal
Product NDC 54312-230
11-digit product format 543120230
Labeler code 54312
Product ID 54312-230_4c4d682d-dea0-cfe0-e063-6394a90a741e
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE
Dosage form AEROSOL, POWDER
Route TOPICAL
Labeler Compania Internacional de Comercio, S.A.P.I. de C.V.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-13
Substance TOLNAFTATE
Active strength 10 mg/g
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 Derman Antifungal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 10 mg/g
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 705934 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 54312-230-01 Derman Antifungal 130 g in 1 BOTTLE, SPRAY AEROSOL, POWDER 130 3
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 54312-230-01 54312023001 130 g in 1 BOTTLE, SPRAY (54312-230-01) 130 g 2025-11-13 No No Current