Home NDC 81522-068 Tolnaftate
Product NDC 81522-068
11-digit product format 815220068
Labeler code 81522
Product ID 81522-068_422aabe0-794f-fa4e-e063-6394a90a5fdc
Type HUMAN OTC DRUG
Nonproprietary name Antifungal Spray Liquid
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler FSA Store Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-08
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 Tolnaftate
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 313421 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 81522-068-01 Tolnaftate 150 g in 1 CAN AEROSOL, SPRAY 150 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-068 TOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [FSA STORE INC.] 3 Current NDC, 1 package rows 20241109_fb34c5ae-2c6d-700d-e053-6394a90a909f.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 81522-068-01 81522006801 150 g in 1 CAN (81522-068-01) 150 g 2023-05-08 No No Current