Home NDC 11523-0165 Tinactin
Product NDC 11523-0165
11-digit product format 115230165
Labeler code 11523
Product ID 11523-0165_4526e2eb-ee8c-3ac4-e063-6394a90a133f
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Bayer HealthCare LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 1993-09-23
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 209674 Internal RxNorm lookup 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 11523-0165-3 Tinactin 150 g in 1 CAN AEROSOL, SPRAY 150 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tolnaftate ACTIVE INGREDIENT 06KB629TKV TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.] 1 Tolnaftate ACTIVE MOIETY 06KB629TKV TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.] 1 butylated hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.] 1 isobutane INACTIVE INGREDIENT BXR49TP611 TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.] 1 PPG-12-buteth-16 INACTIVE INGREDIENT 58CG7042J1 TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [MSD CONSUMER CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-0165 TINACTIN (TOLNAFTATE) AEROSOL, SPRAY [BAYER HEALTHCARE LLC] 10 Current NDC, Legacy NDC, 1 package rows 20241208_bb878f31-2189-4427-aacf-5bce96d75978.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 23 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 Marketing end Sample Exclude flag Status 11523-0165-3 11523016503 150 g in 1 CAN (11523-0165-3) 150 g 1993-09-23 0000-00-00 No No Current