Home NDC 11523-1190 Tinactin
Product NDC 11523-1190
11-digit product format 115231190
Labeler code 11523
Product ID 11523-1190_4536ed2a-2046-b8ad-e063-6394a90ab95c
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form CREAM
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 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 Tinactin
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103951 Internal RxNorm lookup 209651 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-1190 TINACTIN (TOLNAFTATE) CREAM [BAYER HEALTHCARE LLC.] 13 Current NDC, Legacy NDC, 4 package rows 20241208_c3b715a9-233a-401a-ba60-f78c1ddf1ded.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 36 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 11523-1190-1 11523119001 1 TUBE in 1 CARTON (11523-1190-1) / 15 g in 1 TUBE 1 tube 2002-12-12 0000-00-00 No No Current 11523-1190-2 11523119002 1 TUBE in 1 CARTON (11523-1190-2) / 30 g in 1 TUBE 1 tube 2002-12-12 0000-00-00 No No Current