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 48 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.b9909c59-02e7-4d6c-aa2b-206f1ab4d02c2023-11-14WarningsExact identifier
application number: M005
FLUSH Maximum Strength Antifungal formulaUNDECYLENIC ACIDTriple Point Group, LLC1d9e56ef-c7c9-4aff-ab9e-b163e566e3d52023-11-11WarningsExact identifier
application number: M005
SIMPLY VITAL Antifungal CreamCLOTRIMAZOLEALPHA PLANTS INCd3842de3-0d13-4dc2-920b-90a4b822bbb82023-11-11WarningsExact identifier
application number: M005
CLARUS AC Antifungal SolutionTOLNAFTATEClinical Therapeutic Solutions28ab9f1b-65cd-4405-a9a3-f3c9b836693d2023-11-10WarningsExact identifier
application number: M005
Signature Black Bottle Tea Tree Antifungal Foot and Body WashTOLNAFTATERestoration Rockstar, Llc (dba: Kroning Signature Black Bottle)2c966d97-30f5-4942-b64d-742884ce6a2f2023-11-10WarningsExact identifier
application number: M005
Smooth Gator Fungus EliminatorCLOTRIMAZOLESmooth Gator, LLC262b04f5-1b5d-4c67-a557-01f8b17113022023-11-10WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEGeri-Care Pharmaceuticals, Corpf9e60430-eec1-4bc2-9522-eb5aa527d90a2023-11-08WarningsExact identifier
application number: M005
Terrasil Jock Itch Treatment Maximum StrengthCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCc62fbf23-5d19-44ab-9c1a-e9b803192ed02023-11-08WarningsExact identifier
application number: M005
terrasil The Fungal Solution KitCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9a5eb581-62a2-41fe-a174-e852fc47e2352023-11-08WarningsExact identifier
application number: M005
EmoniNail AntifungalUNDECYLENIC ACIDGG Healthworks Inc.84ace47a-d3ae-4735-87b6-dbbf1c40cf542023-11-06WarningsExact identifier
application number: M005
CIDACIN Antifungal TreatmentTOLNAFTATEPedicis Research LLCbd53a9e3-65c8-4834-8e23-a2a928b83a662023-11-05WarningsExact identifier
application number: M005
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions7e8897ff-67d1-4336-866e-cb76a36edddc2023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions308a91d1-3511-4e2d-a62f-a31d77d70e062023-11-05WarningsExact identifier
application number: M005
Human Science Antifungal Foot CareUNDECYLENIC ACIDHUMAN SCIENCE, LLC26b2519b-7d7b-4b33-b5d6-a41fe6f735382023-11-05WarningsExact identifier
application number: M005
HomeHealth AntifungalTOLNAFTATEHome Health895cd24c-3f78-4e2e-bf98-8bb6605798da2023-11-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LP800a9dab-d287-427e-af6d-26996e0def412023-11-01WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE-IODINEDr Radows58e1757c-45ce-455e-bd64-a9e99cd3680f2023-10-30WarningsExact identifier
application number: M005
JOCK-EZECLOTRIMAZOLEBentlin Products LLCd3ff5bfb-2e0f-4daa-84b3-4a3016ca92802023-10-30WarningsExact identifier
application number: M005
TheraPlus PlusCLOTRIMAZOLEZhejiang Jingwei Pharmaceutical Co., Ltd.de75179d-1889-4823-9f39-4bebdf185d762023-10-27WarningsExact 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