Home NDC 85283-001 Nail Antifungal Treatment
Product NDC 85283-001
11-digit product format 852830001
Labeler code 85283
Product ID 85283-001_4a9c8198-0dec-8302-e063-6394a90afcb3
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate 1% FUNGI NAIL
Dosage form LIQUID
Route TOPICAL
Labeler BENM INC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-21
Substance SALICYLIC ACID; TOLNAFTATE
Active strength 5; 1 mg/100mL; mg/100mL
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 Nail Antifungal Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 5 mg/100mL TOLNAFTATE 1 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup 06KB629TKV Internal UNII 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 85283-001-01 Nail Antifungal Treatment 30 mL in 1 BOTTLE LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85283-001 NAIL ANTIFUNGAL TREATMENT (TOLNAFTATE 1% FUNGI NAIL) LIQUID [BENM INC] 1 Current NDC, 1 package rows 20250223_2ea24785-c648-4104-e063-6294a90ab12f.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85283-001-01 85283000101 30 mL in 1 BOTTLE (85283-001-01) 30 ml 2025-02-21 No No Current