FDA.reportPublic FDA data

CLARUS Antifungal

Product NDC
44577-001
11-digit product format
445770001
Labeler code
44577
Product ID
44577-001_0973b73d-5dc0-0986-e063-6294a90a5917
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-07
Substance
TOLNAFTATE
Active strength
1 g/100g
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/100g

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
103951Internal RxNorm lookup
1299059Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7e8897ff-67d1-4336-866e-cb76a36edddcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-001-01CLARUS Antifungal45 g in 1 TUBECREAM456

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
TOLNAFTATEACTIVE MOIETY06KB629TKVCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
LAURETH-7INACTIVE INGREDIENTZ95S6G8201CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YICLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
UREAINACTIVE INGREDIENT8W8T17847WCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2
WATERINACTIVE INGREDIENT059QF0KO0RCLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-001CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231106_7e8897ff-67d1-4336-866e-cb76a36edddc.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 31 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Antifungal LiquidTOLNAFTATEFSA Store Inc.fae36294-68b6-bf14-e053-6394a90aaacd2025-10-27WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.58dd955e-e68b-4fbd-90c8-a85b15c00dc72025-10-25WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.1360cdd8-b2b2-4af9-b6ff-af1101d49e182025-10-25WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYBetter Living Brands LLCccff8d63-ee7d-eada-e053-2995a90ac5dd2025-10-24WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYBetter Living Brands LLCccff4830-6d81-2a0d-e053-2a95a90a154c2025-10-24WarningsExact identifier
application number: M005
Liquid Antifungal TreatmentTOLNAFTATEHudson Health LLC14a9efd8-e49f-12fa-e063-6394a90aa8a02025-10-24WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsExact identifier
application number: M005
Signature Care Antifungal Cream Tolnaftate 1%TOLNAFTATEBETTER LIVING BRANDS LLCb02b81d6-8db4-927b-e053-2995a90a39582025-10-24WarningsExact identifier
application number: M005
Winco Foods TolnaftateTOLNAFTATEWinco Foods, LLC218f7613-1401-4f1b-bf46-576b536825af2025-10-23WarningsExact identifier
application number: M005
zourunan MULTI-PURPOS TREATMENTMULTI-PURPOS TREATMENTGuchutang Biotechnology (Longyan) Co., Ltd41bad254-b674-9521-e063-6294a90ab6342025-10-22WarningsExact identifier
application number: M005
zourunan FOOT ODOR PROBIOTICFOOT ODORGuchutang Biotechnology (Longyan) Co., Ltd41bbc02c-53f2-2d94-e063-6394a90ac9ec2025-10-22WarningsExact identifier
application number: M005
Signature Care Athletes FootCLOTRIMAZOLESafewayc1750c17-4afb-aecf-e053-2a95a90af35b2025-10-22WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEImperial Feet B.V.1189c7d8-7c8f-ae01-e063-6294a90ac2702025-10-21WarningsExact identifier
application number: M005
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
application number: M005
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEQuantum, Inc.6cb95707-9831-41f1-a23e-9e3356141fdc2025-10-20WarningsExact identifier
application number: M005
Toe FungusTOLNAFTATEImperial Feet B.V.118a6c97-4e8a-050a-e063-6294a90a11082025-10-17WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangzhou Haishi Biological Technology Co., Ltd.4141574d-7a5b-c437-e063-6394a90aacb62025-10-16WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHY-VEE, INC415ecf9b-460d-82b6-e063-6294a90a0e052025-10-16WarningsExact identifier
application number: M005
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299059Clarus 1 % Topical CreamPSN7e8897ff-67d1-4336-866e-cb76a36edddc6
103951tolnaftate 1 % Topical CreamPSN7e8897ff-67d1-4336-866e-cb76a36edddc6
1299059tolnaftate 10 MG/ML Topical Cream [Clarus]SBD7e8897ff-67d1-4336-866e-cb76a36edddc6
103951tolnaftate 10 MG/ML Topical CreamSCD7e8897ff-67d1-4336-866e-cb76a36edddc6
1299059Clarus 1 % Topical CreamSY7e8897ff-67d1-4336-866e-cb76a36edddc6
1299059Clarus 10 MG/ML Topical CreamSY7e8897ff-67d1-4336-866e-cb76a36edddc6
103951tolnaftate 1 % Topical CreamSY7e8897ff-67d1-4336-866e-cb76a36edddc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44577-001-014457700010145 g in 1 TUBE (44577-001-01) 45 g2017-02-050000-00-00NoNoCurrent