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 50 of 51 · 1,004 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EmoniNail Antifungal UNDECYLENIC ACID GG Healthworks Inc. 84ace47a-d3ae-4735-87b6-dbbf1c40cf54 2023-11-06 Warnings Exact identifier application number: M005 CIDACIN Antifungal Treatment TOLNAFTATE Pedicis Research LLC bd53a9e3-65c8-4834-8e23-a2a928b83a66 2023-11-05 Warnings Exact identifier application number: M005 MacerRx Web MICONAZOLE NITRATE Clinical Therapeutic Solutions c9327f41-10f1-41f3-855b-838c701d6767 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 7e8897ff-67d1-4336-866e-cb76a36edddc 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 308a91d1-3511-4e2d-a62f-a31d77d70e06 2023-11-05 Warnings Exact identifier application number: M005 Human Science Antifungal Foot Care UNDECYLENIC ACID HUMAN SCIENCE, LLC 26b2519b-7d7b-4b33-b5d6-a41fe6f73538 2023-11-05 Warnings Exact identifier application number: M005 HomeHealth Antifungal TOLNAFTATE Home Health 895cd24c-3f78-4e2e-bf98-8bb6605798da 2023-11-05 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Proficient Rx LP 800a9dab-d287-427e-af6d-26996e0def41 2023-11-01 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE-IODINE Dr Radows 58e1757c-45ce-455e-bd64-a9e99cd3680f 2023-10-30 Warnings Exact identifier application number: M005 JOCK-EZE CLOTRIMAZOLE Bentlin Products LLC d3ff5bfb-2e0f-4daa-84b3-4a3016ca9280 2023-10-30 Warnings Exact identifier application number: M005 TheraPlus Plus CLOTRIMAZOLE Zhejiang Jingwei Pharmaceutical Co., Ltd. de75179d-1889-4823-9f39-4bebdf185d76 2023-10-27 Warnings Exact identifier application number: M005 Evercare Antifungal Treatment Super Absorbent Powder MICONAZOLE NITRATE PANEFFORT, LLC f91910f3-b461-43a4-9120-fda69483fffa 2023-10-26 Warnings Exact identifier application number: M005 Thera plus Antifungal Clotrimazole CLOTRIMAZOLE FOURSTAR GROUP USA, INC. 1265be99-8922-4b76-bd63-19bfb42c3896 2023-10-26 Warnings Exact identifier application number: M005 Thera plus Antifungal Tolnaftate TOLNAFTATE FOURSTAR GROUP USA, INC. c628dda8-7a6d-5f3a-e053-2995a90a35f8 2023-10-26 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE IODINE Jianerkang Medical Co., Ltd e1789944-3a41-4c86-b173-3a6993ae2141 2023-10-23 Warnings Exact identifier application number: M005 Povidone Iodine Impregnated POVIDONE IODINE Jianerkang Medical Co., Ltd 14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d 2023-10-23 Warnings Exact identifier application number: M005 Povidone Iodine Impregnated POVIDONE IODINE Jianerkang Medical Co., Ltd b82cea56-b09f-411d-a6cf-c53b3ce0e3b6 2023-10-23 Warnings Exact identifier application number: M005 Povidone Iodine Scrub POVIDONE-IODINE Jianerkang Medical Co., Ltd 78131b57-1ffc-4eb8-821e-f7bb73300fe9 2023-10-23 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE IODINE Jianerkang Medical Co., Ltd eb30e5de-9074-4760-8e92-e1d1c127227d 2023-10-23 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE IODINE Jianerkang Medical Co., Ltd 0bd3de76-b726-41f1-87bc-14ab8a1eca8e 2023-10-23 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