Home NDC 83837-001 Toe Fungus
Product NDC 83837-001
11-digit product format 838370001
Labeler code 83837
Product ID 83837-001_4162e05b-0726-b310-e063-6294a90a0fa0
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form SOLUTION
Route TOPICAL
Labeler Imperial Feet B.V.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-19
Substance TOLNAFTATE
Active strength 1 g/100mL
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 Toe Fungus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100mL
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 313423 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 83837-001-01 Toe Fungus 75 mL in 1 BOTTLE, DROPPER SOLUTION 75 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83837-001 TOE FUNGUS (TOLNAFTATE) SOLUTION [IMPERIAL FEET B.V.] 4 Current NDC, 1 package rows 20250327_118a6c97-4e8a-050a-e063-6294a90a1108.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 83837-001-01 83837000101 75 mL in 1 BOTTLE, DROPPER (83837-001-01) 75 ml 2024-02-19 No No Current