Home NDC 11527-051 Tolnaftate
Product NDC 11527-051
11-digit product format 115270051
Labeler code 11527
Product ID 11527-051_b4271182-7791-423e-8335-dfd5cb5d859b
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE
Dosage form CREAM
Route TOPICAL
Labeler Sheffield Pharmaceuticals LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-10-07
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 103951 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 11527-051-40 Tolnaftate 1 in 1 CARTON CREAM 1 5 11527-051-40 Tolnaftate 35.4 g in 1 TUBE CREAM 35.4 5 11527-051-51 Tolnaftate 1 in 1 CARTON CREAM 1 5 11527-051-51 Tolnaftate 14 g in 1 TUBE CREAM 14 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-051 TOLNAFTATE CREAM [SHEFFIELD PHARMACEUTICALS LLC] 5 Current NDC, Legacy NDC, 4 package rows 20250223_ca52af37-c3a2-414c-a24a-a37a92925133.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 Marketing end Sample Exclude flag Status 11527-051-40 11527005140 1 TUBE in 1 CARTON (11527-051-40) / 35.4 g in 1 TUBE 1 tube 2009-10-07 0000-00-00 No No Current 11527-051-51 11527005151 1 TUBE in 1 CARTON (11527-051-51) / 14 g in 1 TUBE 1 tube 2009-10-07 0000-00-00 No No Current