Home NDC 68016-152 Tolnaftate Cream 1%
Product NDC 68016-152
11-digit product format 680160152
Labeler code 68016
Product ID 68016-152_29b74830-546d-c90b-e063-6294a90a4e72
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form CREAM
Route TOPICAL
Labeler Pharmacy Value Alliance, LLC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-08-23
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 Tolnaftate Cream 1%
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-152-01 Tolnaftate Cream 1% 1 in 1 BOX CREAM 1 5 68016-152-01 Tolnaftate Cream 1% 28 g in 1 TUBE CREAM 28 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-152 TOLNAFTATE CREAM 1% (TOLNAFTATE) CREAM [PHARMACY VALUE ALLIANCE, LLC.] 5 Current NDC, Legacy NDC, 2 package rows 20241222_3abfd734-229b-1a0e-e054-00144ff88e88.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 68016-152-01 68016015201 1 TUBE in 1 BOX (68016-152-01) / 28 g in 1 TUBE 1 tube 2016-08-31 0000-00-00 No No Current