FDA.reportPublic FDA data

Tolnaftate

Product NDC
24385-032
11-digit product format
243850032
Labeler code
24385
Product ID
24385-032_39fb64e0-2510-e64b-e063-6294a90a89cb
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-02-17
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct24385-032IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage24385-03224385-032-03IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
Brand name suffix
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
a3c9b783-4a36-46b3-a0dc-0696907eaebbAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-032-032020-06-23C16284748780-19d75b9d0-0f97-f424-e053-dadaa90a57ceTolnaftate 1% Cream Antifungal Cream
24385-032-032020-01-31C16284748780-19d75b9d0-0f97-f424-e053-dadaa90a57ceTolnaftate 1% Cream Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-032-03TolnaftateAntifungal30 g in 1 TUBECREAM305
24385-032-03TolnaftateAntifungal1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-032-03GM - Gram24385-03208711039-a5d3-431b-9d16-7eb0349fde9d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [AMERISOURCE BERGEN]2
TolnaftateACTIVE MOIETY06KB629TKVTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [AMERISOURCE BERGEN]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [AMERISOURCE BERGEN]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [AMERISOURCE BERGEN]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [AMERISOURCE BERGEN]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [AMERISOURCE BERGEN]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-032TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [AMERISOURCE BERGEN]4Current NDC, Legacy NDC, 2 package rows20241109_a3c9b783-4a36-46b3-a0dc-0696907eaebb.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 33 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories0b32a369-ea1c-4cb8-8ea1-07bba8f16b722025-09-16WarningsExact identifier
application number: M005
SKIN TAG WART AND CORN REMOVERSALICYLIC ACIDZhenping Renren Industry Co., Ltd.3e6dad69-b301-f7dc-e063-6394a90ad3802025-09-14WarningsExact identifier
application number: M005
FUNGAL NAILS REPAIRING ESSENCEPEPPERMINT OILZhenping Renren Industry Co., Ltd.3e82649c-d784-d64c-e063-6294a90ac95d2025-09-11WarningsExact identifier
application number: M005
equate Athletes FootTOLNAFTATEWal-Mart Stores Ince90297d0-0f87-4ae3-b9b7-959266d57c242025-09-11WarningsExact identifier
application number: M005
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.3e7d22b0-2f57-fcac-e063-6394a90aefd92025-09-10WarningsExact identifier
application number: M005
Amerfresh Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltdcdc4f0ff-07bd-47c8-850b-1698308bb6602025-09-09WarningsExact identifier
application number: M005
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEEncube Ethicals, Inc.afbc28f8-bb76-424d-9d73-136e6c283ead2025-09-04WarningsExact identifier
application number: M005
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
application number: M005
Extra Strength Nail Fungus TreatmentUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abc0892-e52b-a40f-e063-6294a90a0e352025-09-02WarningsExact identifier
application number: M005
Hermon Balanitis CreamSULFUR 1X HPUSBeautivity LLC3dba4e4b-8224-6a96-e063-6394a90a91292025-09-01WarningsExact identifier
application number: M005
CaseysBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.a29d6c19-01aa-45b0-92cd-3f1148bad4f82025-08-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEVALU MERCHANDISERS, CO.1d258684-9034-460c-953d-78e2b51981672025-08-26WarningsExact identifier
application number: M005
Femmesil Maximum StrengthMICONAZOLE NITRATEAidance Skincare & Topical Solutions, LLCd8b01fe1-4465-497b-909e-f51f31fdf8332025-08-25WarningsExact identifier
application number: M005
femmesil Ultra TherapyCLOTRIMAZOLEAidance Scientific, Inc.3d36794a-07d0-860c-e063-6294a90a6e8f2025-08-25WarningsExact identifier
application number: M005
Nedtol Folliculitis Treatment CreamsMICONAZOLE NITRATEJiashen International Trade Limited3d0a1e39-82e4-9337-e063-6294a90aa9a32025-08-23WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLC6b74d405-42d6-4c46-ba78-3007d1e8ffb82025-08-23WarningsExact identifier
application number: M005
FUNGLARA Anti FungalUNDECYLENIC ACIDFUNGLARA LLCa23c2399-36ea-4f22-8140-066e22c9a8622025-08-20WarningsExact identifier
application number: M005
Rapid MicroGelTOLNAFTATEThe Tetra Corporationafb6d7c4-1f75-4694-83c8-d6469250d6a12025-08-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNa3c9b783-4a36-46b3-a0dc-0696907eaebb5
103951tolnaftate 10 MG/ML Topical CreamSCDa3c9b783-4a36-46b3-a0dc-0696907eaebb5
103951tolnaftate 1 % Topical CreamSYa3c9b783-4a36-46b3-a0dc-0696907eaebb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24385-032-03243850032031 TUBE in 1 CARTON (24385-032-03) / 30 g in 1 TUBE1 tube2006-02-170000-00-00NoNoCurrent