FDA.reportPublic FDA data

CLARUS Antifungal

Product NDC
44577-470
11-digit product format
445770470
Labeler code
44577
Product ID
44577-470_126eb818-7e35-3cce-e063-6294a90a5e69
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-11
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLARUS 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
835c3c23-fc3c-404e-8e87-5a0176126730Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-470-00CLARUS Antifungal1 in 1 BOXCREAM11
44577-470-00CLARUS Antifungal85 g in 1 TUBECREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-470CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1Current NDC, 2 package rows20240312_835c3c23-fc3c-404e-8e87-5a0176126730.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 1 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Original Mane n Tail Daily Control 2 in 1 Anti DandruffPYRITHIONE ZINCStraight Arrow Products Inc68ab55d6-b1a9-46c0-87f0-ec12ad3474bc2026-07-09WarningsExact identifier
application number: M
Stool Softener LaxativeDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.c1f588d0-4600-4b97-b2d3-2c08ac351e072026-06-30WarningsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.66ca7a94-378b-4476-8060-d9c6f82f57fc2026-06-12WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Health3d17aba0-220f-42c4-9e26-5c44857847cd2026-05-20Warnings, Adverse reactionsExact identifier
application number: M
IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral RichHOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc2a44a019-0cc0-439b-aaa5-37582ec5492e2026-05-14WarningsExact identifier
application number: M
THORACOLHONEY LEMON COUGH DROPSHART Healthfee9f594-c619-4d77-bb52-632078e0254e2026-04-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Health07d447f1-469c-4e34-b807-ede9a449e6ab2026-04-15WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE CREAMHART Healthc76fb030-cbb5-4773-aa52-d038cb41d0af2026-04-15WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEAmazon.com Services LLC55b0d905-fcc0-40ba-a5dd-331a27a3a2092026-04-07Warnings, Adverse reactionsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
application number: M
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
application number: M
Relief-PEACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINEHART Health9475fb51-931b-4a89-be6b-62e715d0883e2026-01-15WarningsExact identifier
application number: M
ASPIRINASPIRINHART Healtha1c73edf-861d-478b-9d3c-0eddcc6879cc2026-01-14WarningsExact identifier
application number: M
HISTAPRINDIPHENHYDRAMINENorMed38786a65-a12b-4479-b63c-b7c15410da042026-01-14WarningsExact identifier
application number: M
Blood ClottingBENZETHONIUM CHLORIDE AND LIDOCAINEHART Health21668731-8b8a-404f-80ab-962a0a9d5f632026-01-14WarningsExact identifier
application number: M
BandageBENZOCAINE AND BENZETHONIUM CHLORIDEHART Health6de57472-6dd0-43b6-8a82-fe459fa99ddb2026-01-14WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINE, ISOPROPYL ALCOHOLHART Healthc0e7d661-a9c9-4656-a516-57552848ebe82026-01-12WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLHART Health8d01b10b-7916-420e-9d44-ebd3806fe3152026-01-12WarningsExact identifier
application number: M
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
application number: M
NUTRALOXCALCIUM CARBONATEHART Health3941b84e-3b4b-46eb-851b-979bac1ae9972025-12-31WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN835c3c23-fc3c-404e-8e87-5a01761267301
103951tolnaftate 10 MG/ML Topical CreamSCD835c3c23-fc3c-404e-8e87-5a01761267301
103951tolnaftate 1 % Topical CreamSY835c3c23-fc3c-404e-8e87-5a01761267301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44577-470-00445770470001 TUBE in 1 BOX (44577-470-00) / 85 g in 1 TUBE1 tube2024-03-11NoNoCurrent