FDA.reportPublic FDA data

Athletes Foot

Product NDC
83837-002
11-digit product format
838370002
Labeler code
83837
Product ID
83837-002_31381b57-0c5e-cee7-e063-6294a90ae765
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Imperial Feet B.V.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-19
Substance
TOLNAFTATE
Active strength
1 g/100mL
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
Athletes Foot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL

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
313423Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1189c7d8-7c8f-ae01-e063-6294a90ac270Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83837-002-01Athletes Foot75 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83837-002ATHLETES FOOT (TOLNAFTATE) SOLUTION/ DROPS [IMPERIAL FEET B.V.]2Current NDC, 1 package rows20241016_1189c7d8-7c8f-ae01-e063-6294a90ac270.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 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
TolnaftateODOR CONTROL POWDER SPRAYWalgreen Companya113f568-bd20-4f02-8e09-1b8223a0a9fa2025-12-16WarningsExact identifier
application number: M005
Tobcharm Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.45f92be2-0677-5989-e063-6394a90af2802025-12-15WarningsExact identifier
application number: M005
TEA TREE Oil ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD45bd3ad0-a0d1-314f-e063-6394a90a9a3a2025-12-12WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREETopco Associates LLC97334166-1dff-4ed2-ad31-f524b22097f92025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEMeijer Distribution Inc03fd2680-0040-aa8c-e063-6294a90a090f2025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEPremier Brands of America Inc.edb0a2da-aaa1-3b9b-e053-2995a90a50122025-12-12WarningsExact identifier
application number: M005
PedikleerTOLNAFTATERising Pharma Holdings, Inc.83396c51-7107-4d98-9d80-ebf6584f4dc82025-12-11WarningsExact identifier
application number: M005
ELAIMEI FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.457d08eb-e812-8f12-e063-6294a90ab85f2025-12-10WarningsExact identifier
application number: M005
Lofuanna FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.43da9ec2-5f2f-dfce-e063-6394a90aecca2025-12-10WarningsExact identifier
application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%UNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.457f819b-0850-a97c-e063-6394a90ac3682025-12-09WarningsExact identifier
application number: M005
NAIL REPAIR PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd45814b84-0e51-6c9d-e063-6394a90a29052025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAYBetter Living Brandsccfef81b-f271-4551-e053-2a95a90a8ac42025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREEFoodhold USAa64c9371-0ac7-4c47-bc12-7bc77162b2442025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEHarris Teeter, LLC02eb9c78-5a89-4958-b5a4-68f39e584cf22025-12-09WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSN1189c7d8-7c8f-ae01-e063-6294a90ac2703
313423tolnaftate 10 MG/ML Topical SolutionSCD1189c7d8-7c8f-ae01-e063-6294a90ac2703
313423tolnaftate 1 % Topical SolutionSY1189c7d8-7c8f-ae01-e063-6294a90ac2703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83837-002-018383700020175 mL in 1 BOTTLE, DROPPER (83837-002-01) 75 ml2024-02-19NoNoCurrent