Home NDC 85424-001 Antifungal Medicated Bar
Product NDC 85424-001
11-digit product format 854240001
Labeler code 85424
Product ID 85424-001_31305ed2-a0a1-6d4c-e063-6294a90a6ba5
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form SOAP
Route TOPICAL
Labeler RoyceDerm LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-20
Substance TOLNAFTATE
Active strength 10 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Antifungal Medicated Bar
Listing expiration 2026-12-31 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 1807715 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 85424-001-01 Antifungal Medicated Bar 232 g in 1 CARTON SOAP 232 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85424-001 ANTIFUNGAL MEDICATED BAR (TOLNAFTATE) SOAP [ROYCEDERM LLC] 1 Current NDC, 1 package rows 20250420_31305ed2-a0a0-6d4c-e063-6294a90a6ba5.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 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 85424-001-01 85424000101 232 g in 1 CARTON (85424-001-01) 232 g 2025-04-20 No No Current