FDA.reportPublic FDA data

WINCO ANTIFUNGAL

Product NDC
67091-051
11-digit product format
670910051
Labeler code
67091
Product ID
67091-051_f27bd705-6df0-4fcd-bc25-0324897f1226
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
WinCo Foods LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-30
Substance
TOLNAFTATE
Active strength
10 mg/g
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
WINCO ANTIFUNGAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

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
103951Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46b58c71-d62e-4b3d-b2ec-65407032eeeaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-051-28WINCO ANTIFUNGAL28 g in 1 TUBECREAM283
67091-051-28WINCO ANTIFUNGAL1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-051WINCO ANTIFUNGAL (TOLNAFTATE 1%) CREAM [WINCO FOODS LLC]3Current NDC, Legacy NDC, 2 package rows20241122_46b58c71-d62e-4b3d-b2ec-65407032eeea.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 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Scholls Instant Cool Athletes Foot WipesTOLNAFTATECosco International, Inc.cde656a9-7841-4a73-a2f4-f5a76a3e15c12025-02-06WarningsExact identifier
application number: M005
Silka Athletes FootMICONAZOLE NITRATEGenomma Lab USA307104a2-2df6-43b0-bf3f-f4d93d3e40f12025-02-05WarningsExact identifier
application number: M005
MICONAZOLE NitrateMICONAZOLE NITRATENuCare Pharmaceuticals,Inc.fd7dd2eb-03a7-ef1f-e053-6294a90a85572025-02-04WarningsExact identifier
application number: M005
Molecular AFTOLNAFTATERenu Laboratories, LLC1b47e687-29cf-48ce-8bc3-ac8f44f05baa2025-02-03WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Papalo Group LLC2d2c0e12-123d-75bd-e063-6394a90ae5462025-01-31WarningsExact identifier
application number: M005
70% Isopropyl AlcoholISOPROPYL ALCOHOLIDO PHARMd5833c6f-81dd-6ff6-e053-2995a90ac76d2025-01-30WarningsExact identifier
application number: M005
AWAS ALCOHOLSPRAYALCOHOLIDO PHARM03010837-0289-3e08-e063-6394a90a7d042025-01-30WarningsExact identifier
application number: M005
ELON Dual Defense Anti Fungal FormulaUNDECYLENIC ACIDLittle Giant Holdings LLC45c4567d-7876-6459-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M005
DCH Labs Antifungal JockMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCfc749882-2e1e-cad3-e053-6294a90a33ca2025-01-27WarningsExact identifier
application number: M005
Antifungal PenUNDECYLENIC ACID 25%XF Agencija Limiteda15d4512-0fc6-424f-9dd3-ab433d9b7a262025-01-27WarningsExact identifier
application number: M005
Mata HongosUNDECYLENIC ACIDVitamex USA, Corp21ca7edb-dde3-5846-e063-6394a90a3cc02025-01-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd53cb4c0d-40b5-4cf3-b122-fd6dd654883f2025-01-23WarningsExact identifier
application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGALTOLNAFTATENatureplex, LLC575b8645-9166-4242-a74f-f4aa4acaaf3d2025-01-15WarningsExact identifier
application number: M005
Tobcharm Antifungal Treatment CreamANTIFUNGAL TREATMENT CREAMGuangzhou Zanming Trading Co., Ltd.2ba241cc-2767-1190-e063-6294a90ac66b2025-01-13WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2%MICONAZOLE NITRATEAkron Pharma Inc.8933f939-098a-4257-8d9c-4d5c3240e9a62025-01-10WarningsExact identifier
application number: M005
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact identifier
application number: M005
ClotrimazoleDRS. CLOTRIMAZOLEOL PHARMA TECH,LLCb0e9fc77-6d5c-2472-e053-2995a90a3de42025-01-09WarningsExact identifier
application number: M005
Anti-Bacterial WipesBENZALKONIUM CHLORIDETongling Jieya Biological Technology Co., Ltd.d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d2025-01-04WarningsExact identifier
application number: M005
AVON HeXashield Athletes Foot CreamTOLNAFTATETai Guk Pharm. Co., Ltd.8f2b6a09-8cb0-0d17-e053-2995a90aa07f2025-01-01WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE 1%Trifecta Pharmaceuticals USA, LLC091b907f-544a-86c9-e063-6294a90a5d872024-12-31WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN46b58c71-d62e-4b3d-b2ec-65407032eeea3
103951tolnaftate 10 MG/ML Topical CreamSCD46b58c71-d62e-4b3d-b2ec-65407032eeea3
103951tolnaftate 1 % Topical CreamSY46b58c71-d62e-4b3d-b2ec-65407032eeea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-051-28670910051281 TUBE in 1 CARTON (67091-051-28) / 28 g in 1 TUBE1 tube2022-04-300000-00-00NoNoCurrent