Home NDC 11523-0139 Tinactin
Product NDC 11523-0139
11-digit product format 115230139
Labeler code 11523
Product ID 11523-0139_4526df19-7a71-0f19-e063-6394a90a3954
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form AEROSOL, POWDER
Route TOPICAL
Labeler Bayer HealthCare LLC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-29
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 Tinactin
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 705934 Internal RxNorm lookup 705936 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 11523-0139-1 Tinactin 133 g in 1 CAN AEROSOL, POWDER 133 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-0139 TINACTIN (TOLNAFTATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.] 2 Current NDC, 1 package rows 20240524_0beda157-efd2-5245-e063-6394a90a6911.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 11523-0139-1 11523013901 133 g in 1 CAN (11523-0139-1) 133 g 2023-11-29 No No Current