FDA.reportPublic FDA data

CLARUS Antifungal

Product NDC
44577-002
11-digit product format
445770002
Labeler code
44577
Product ID
44577-002_09740b13-55d0-2604-e063-6294a90a158c
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-07
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
CLARUS Antifungal
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup
1299066Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
308a91d1-3511-4e2d-a62f-a31d77d70e06Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-002-01CLARUS Antifungal15 mL in 1 BOTTLESOLUTION156

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVCLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2
TOLNAFTATEACTIVE MOIETY06KB629TKVCLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHCLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2
SESAME OILINACTIVE INGREDIENTQX10HYY4QVCLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YICLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-002CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231106_308a91d1-3511-4e2d-a62f-a31d77d70e06.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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact identifier
application number: M005
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.a2b9570f-312c-4f46-994d-efe057b247aa2025-07-28WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.b41b130f-48fd-47d4-a94e-74433ae44de22025-07-28WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
application number: M005
HongocuraUNDECYLENIC ACID, ZINC UNDECYLENATEMENPER DISTRIBUTORS, INC.c69b735e-0ffe-4328-bd9f-3c1ac6798c082025-07-22WarningsExact identifier
application number: M005
Hongocura PinceladasUNDECYLENIC ACIDMenper Distributors, Inc.4b9a3a70-d646-47c6-b969-5c4d759d23a42025-07-22WarningsExact identifier
application number: M005
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
application number: M005
Hongocura SUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.4a21f371-bfc1-4e66-af16-55b3283872b72025-07-22WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
application number: M005
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.TEA TREE OIL ANTIFUNGAL SOAP.Shenzhen Xinxin Yunhai Technology Co., Ltd.3a0860b0-346e-7024-e063-6394a90ace812025-07-16WarningsExact identifier
application number: M005
TopCare AntifungalCLOTRIMAZOLETopco Associates LLC6757eb2a-73e0-4bd0-a332-5713fdf3445d2025-07-16WarningsExact identifier
application number: M005
UpandUp ClotrimazoleCLOTRIMAZOLETarget Corporationcb2b7d38-9988-493b-9843-56c2f59eed2f2025-07-16WarningsExact identifier
application number: M005
Jock ItchCLOTRIMAZOLETARGET Corporation1ae551e7-69de-4eef-b4f7-5e1a880e631d2025-07-16WarningsExact identifier
application number: M005
Athletes FootCLOTRIMAZOLEFRED'S, INC.d2d8f44e-2dfa-446b-855e-86e0d6d2d0df2025-07-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299066CLARUS 1 % Topical SolutionPSN308a91d1-3511-4e2d-a62f-a31d77d70e066
313423tolnaftate 1 % Topical SolutionPSN308a91d1-3511-4e2d-a62f-a31d77d70e066
1299066tolnaftate 10 MG/ML Topical Solution [Clarus]SBD308a91d1-3511-4e2d-a62f-a31d77d70e066
313423tolnaftate 10 MG/ML Topical SolutionSCD308a91d1-3511-4e2d-a62f-a31d77d70e066
1299066Clarus 1 % Topical SolutionSY308a91d1-3511-4e2d-a62f-a31d77d70e066
1299066Clarus 10 MG/ML Topical SolutionSY308a91d1-3511-4e2d-a62f-a31d77d70e066
313423tolnaftate 1 % Topical SolutionSY308a91d1-3511-4e2d-a62f-a31d77d70e066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44577-002-014457700020115 mL in 1 BOTTLE (44577-002-01) 15 ml2017-02-060000-00-00NoNoCurrent