Tolnaftate Cream 1%

Product NDC
68016-152
11-digit product format
680160152
Labeler code
68016
Product ID
68016-152_29b74830-546d-c90b-e063-6294a90a4e72
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmacy Value Alliance, LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-23
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
Tolnaftate Cream 1%
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
3abfd734-229b-1a0e-e054-00144ff88e88Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-09Tolnaftate Cream 1%
2023-01-30Tolnaftate Cream 1%
2021-08-10Tolnaftate Cream 1%
2021-01-29Tolnaftate Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-152-01Tolnaftate Cream 1%1 in 1 BOXCREAM15
68016-152-01Tolnaftate Cream 1%28 g in 1 TUBECREAM285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-152-01EA - Each68016-15201999020-6fdb-4813-a13b-923a8c8acb5612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-152TOLNAFTATE CREAM 1% (TOLNAFTATE) CREAM [PHARMACY VALUE ALLIANCE, LLC.]5Current NDC, Legacy NDC, 2 package rows20241222_3abfd734-229b-1a0e-e054-00144ff88e88.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 30 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateJOCK ITCH SPRAYKroger Co.86bdf8a6-3a1f-457b-e053-2991aa0a58102025-10-30WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE POWDER SPRAYKroger Co.f5c8dccd-8e69-6a01-e053-2a95a90a69722025-10-30WarningsExact identifier
application number: M005
TolnafateFOOT AND SNEAKER SPRAYKroger Co.72243b08-47cf-4db3-b834-b762b7f0ccf92025-10-30WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATEThe Kroger Co.209cd0ed-3029-9137-e063-6394a90aa93d2025-10-30WarningsExact identifier
application number: M005
Antifungal Miconazole Liquid ContinuousMICONAZOLE NITRATEMeijer Distribution Inc030f2a31-334b-a6d8-e063-6394a90a98fc2025-10-30WarningsExact identifier
application number: M005
Jock ItchMICONAZOLE NITRATEMeijer Distribution Inc.030f1316-ab3c-ce37-e063-6394a90a0f882025-10-30WarningsExact identifier
application number: M005
Antifungal Athletes FootMICONAZOLE NITRATEMeijer Distribution Inc030f2a31-3357-a6d8-e063-6394a90a98fc2025-10-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYMeijer Distribution Inc.0370c9fa-b986-3a63-e063-6294a90a76272025-10-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYMeijer Distribution Inc.0423c895-6841-fcd0-e063-6394a90ad7872025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYWinco Foods, LLCcc24f4ca-a403-0dc4-e053-2a95a90a5dad2025-10-29WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWinco Foods, LLCcc251fab-b66c-44f4-e053-2995a90a681a2025-10-29WarningsExact identifier
application number: M005
Remedy AntifungalMICONAZOLE NITRATEMedline Industries, LP021b4a31-d7f6-4921-b4b1-cbe832eecd932025-10-29WarningsExact identifier
application number: M005
Family Care AntifungalTOLNAFTATEUnited Exchange Corp.6301ab99-1757-144a-e053-2a91aa0adb772025-10-29WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEDiscount Drug Mart, Inc37790bf8-6114-84b9-e063-6394a90ad58d2025-10-29WarningsExact identifier
application number: M005
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.052d8d02-2381-1e3a-e063-6394a90aa07e2025-10-29WarningsExact identifier
application number: M005
CVS Health Athletes FootTOLNAFTATECVS Pharmacy, Inc.ab746148-1111-15bc-e053-2a95a90a61f12025-10-29WarningsExact identifier
application number: M005
WinCo Foods AntifungalCLOTRIMAZOLEWinco Foods LLCc2ca0787-267a-10f4-e053-2a95a90a3a332025-10-28WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAY TALC FREEAmerican Sales Company4354b71e-6268-440d-b916-0403c6fc3ddb2025-10-27WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYFoodhold USA5a8427c2-a1b2-44aa-afb3-669c12efed282025-10-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDFSA Store Inc.fb34c5ae-2c6d-700d-e053-6394a90a909f2025-10-27WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN3abfd734-229b-1a0e-e054-00144ff88e885
103951tolnaftate 10 MG/ML Topical CreamSCD3abfd734-229b-1a0e-e054-00144ff88e885
103951tolnaftate 1 % Topical CreamSY3abfd734-229b-1a0e-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-152-01680160152011 TUBE in 1 BOX (68016-152-01) / 28 g in 1 TUBE1 tube2016-08-310000-00-00NoNoCurrent