Home NDC 68016-653 Tolnafate
Product NDC 68016-653
11-digit product format 680160653
Labeler code 68016
Product ID 68016-653_4aa5f166-0e54-6d6c-e063-6394a90a8a62
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate Jock Itch Powder Spray - Talc Free
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Chain Drug Consortium, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-31
Marketing end 2028-06-30
Substance TOLNAFTATE
Active strength 1.3 g/130g
NDC exclude flag No
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 Tolnafate Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1.3 g/130g
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 705934 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 68016-653-46 Tolnafate 130 g in 1 CAN AEROSOL, SPRAY 130 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-653 TOLNAFATE (TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241220_5f9edcf9-b99e-65a2-e053-2a91aa0af565.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 48 of 51 · 1,004 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 68016-653-46 68016065346 130 g in 1 CAN (68016-653-46) 130 g 2017-10-31 2028-06-30 No No Current