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 42 of 51 · 1,004 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Folliculitis Treatment Cream MICONAZOLE NITRATE TAGRID LLC 32396be0-f74a-5483-e063-6294a90ab3ae 2025-04-07 Warnings Exact identifier application number: M005 Antifungal Treatment Liquid 25 undeclylenic Acid UNDECYLENIC ACID SANSAR, LLC 2ae0f300-154e-44c8-bcc3-b5c334e661ac 2025-04-02 Warnings Exact identifier application number: M005 BBlove ALCOHOL WIPES BBLOVE ALCOHOL WIPES Shenzhen Shierjie Biological Engineering Co., LTD 3126955d-8fd1-04f8-e063-6294a90a886f 2025-03-31 Warnings Exact identifier application number: M005 Tagrid Jock Itch Miconazole Nitrate 2% MICONAZOLE NITRATE TAGRID LLC 31abdc68-5027-15e7-e063-6394a90ac4e6 2025-03-31 Warnings Exact identifier application number: M005 Tea Tree Oil Foot Soak and Body Soak ZINC UNDECYLENATE SANSAR, LLC c43816ac-2228-43ce-ba45-80cf3a7788f2 2025-03-28 Warnings Exact identifier application number: M005 health beyond HAND SANITIZER ALCOHOL Nantong Health & Beyond Hygienic Products Inc. e5746be7-e9dc-42a6-a3d0-b386427caec5 2025-03-27 Warnings Exact identifier application number: M005 Tagrit Antifungal Treament Ketoconazole 1% KETOCONAZOLE TAGRID LLC 315a8832-c42f-c07a-e063-6394a90a8218 2025-03-27 Warnings Exact identifier application number: M005 1236-CS Antifungal Powder (Talc Free) 1236-CCANTIFUNGAL POWDER(TALC FREE) Dynarex Corporation 312ba573-4008-83e6-e063-6294a90a4a6d 2025-03-25 Warnings Exact identifier application number: M005 Antifungal Medicated Bar TOLNAFTATE RoyceDerm LLC 31305ed2-a0a0-6d4c-e063-6294a90a6ba5 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antimicrobial Hydrogel Wound Dressing BENZETHONIUM CHLORIDE, THYMOL Lidan, Inc cd5b7a72-1b87-434d-973e-071d2c8a438c 2025-03-25 Warnings Exact identifier application number: M005 Forticept HP Antiseptic Wound Cleanser BENZALKONIUM CHLORIDE, ALLANTOIN Lidan, inc. 41bb46ee-edce-4e1b-bcfd-5c5729e1eb15 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Gel CLOTRIMAZOLE Lidan, Inc. 1b5851fc-ae73-4e54-bb62-3ff928628b97 2025-03-25 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE Preferred Pharmaceuticals Inc. 14d2a661-a490-41ca-b84f-f2be3bc271b4 2025-03-24 Warnings Exact identifier application number: M005 Dermatin Antifungal CLOTRIMAZOLE Melaleuca, Inc. e993fa3b-1d85-46b7-bda5-ed875be74c4e 2025-03-20 Warnings Exact identifier application number: M005 1% ketoconazole KETOCONAZOLE TAGRID LLC 30b75584-3a1e-c125-e063-6294a90acaa7 2025-03-19 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Cream CLOTRIMAZOLE Lidan, Inc. 17abeb4d-b211-4b8c-a9d2-4c7baba2450c 2025-03-07 Warnings Exact identifier application number: M005 Terramed Just Think Comfort Antifungal Medicated Body Wipes TOLNAFTATE Rida LLC 34577389-8e5d-49ab-a208-9c87b6f3cec4 2025-03-06 Warnings Exact identifier application number: M005 Athletes Foot MICONAZOLE NITRATE Rida LLC 85e98ef8-75c3-4be1-b59f-40b5312e2137 2025-03-06 Warnings Exact identifier application number: M005 SOUTH BEACH MULTI-PURPOSE NAIL REPAIR UNDECYLENIC ACID SOUTH BEACH HAIR CARE PROFESIONAL INC 2fb0110c-b275-2a17-e063-6394a90a2d30 2025-03-06 Warnings Exact identifier application number: M005 DG Health Athletes Foot CLOTRIMAZOLE Dolgencorp, Inc. 20370b32-21ad-4362-9b46-c6149c907231 2025-02-28 Warnings Exact identifier application number: M005
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