FDA.reportPublic FDA data

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
IngredientStrength
TOLNAFTATE1.3 g/130g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
705934Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f9edcf9-b99e-65a2-e053-2a91aa0af565Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-653-46Tolnafate130 g in 1 CANAEROSOL, SPRAY1309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-653TOLNAFATE (TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]6Current NDC, Legacy NDC, 1 package rows20241220_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 25 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal LiquidTOLNAFTATELEADER/ Cardinal Health 110, Inc.441f88df-6417-d7db-e063-6394a90a14022025-12-31WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAY - TALC FREELEADER/ Cardinal Health 110, Inc.a9fdd129-9909-4747-bd9f-93a204b507242025-12-31WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREECardinal Healthd90b210b-ade5-4b41-ad34-87f779cbb8ad2025-12-31WarningsExact identifier
application number: M005
Antifungal PowderMICONAZOLE NITRATELEADER/ Cardinal Health 110, Inc.1fcf072b-cf12-967a-e063-6294a90acfc72025-12-31WarningsExact identifier
application number: M005
Lasolex AGMICONAZOLE NITRATEPuretek Corporation4411142f-a8ec-c8c2-e063-6394a90aa25c2025-12-31WarningsExact identifier
application number: M005
Hermon Antifungal Stick1% CLOTRIMAZOLEBeautivity LLC474a5783-4488-034e-e063-6294a90a5de32025-12-31WarningsExact identifier
application number: M005
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
application number: M005
Clotrimazole (Topical Solution), 1%CLOTRIMAZOLEPuro Pharma Inc.cb424fa8-3ed5-45cd-b03f-64675584b34e2025-12-27WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
application number: M005
CuraNails Antifungal PenUNDECYLENIC ACID 25%Quality Discount Inc.3e641d36-72f6-4682-bd31-f7cd04d857f22025-12-25WarningsExact identifier
application number: M005
Opti-Nail 2-in-1TOLNAFTATEKramer Laboratoriesbc8a5492-8bd0-4c80-a270-e4958aeb5ed62025-12-23WarningsExact identifier
application number: M005
ProBliva Medicated Anti FungalANTIFUNGALCAVTECH HOLDING LLC46852aea-028c-71c2-e063-6394a90a80552025-12-22WarningsExact identifier
application number: M005
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
application number: M005
TopCare Antifungal Maximum StrengthUNDECYLENIC ACIDTOPCO ASSOCIATES LLC7c44fb4e-0eef-4ced-b03f-a02ebe6c02642025-12-22WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriesa3ae043b-dc97-449b-b099-70bdf8e924822025-12-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
application number: M005
HC Max Anti-FungalTOLNAFTATEKramer Laboratoriesee99cd87-549f-4a43-878e-b4d5935de0e02025-12-19WarningsExact identifier
application number: M005
Fungi Nail Anti-Fungal PenTOLNAFTATEKramer Laboratories1a0a3b14-d8f2-4363-b3c9-f5028e8eada32025-12-19WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYWinco Foods, LLCcc257a18-247f-c787-e053-2a95a90a075a2025-12-16WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSN5f9edcf9-b99e-65a2-e053-2a91aa0af5659
705934tolnaftate 0.01 MG/MG Powder SpraySCD5f9edcf9-b99e-65a2-e053-2a91aa0af5659
705934tolnaftate 1 % Powder SpraySY5f9edcf9-b99e-65a2-e053-2a91aa0af5659

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-653-4668016065346130 g in 1 CAN (68016-653-46) 130 g2017-10-312028-06-30NoNoCurrent