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
Ingredient	Strength
TOLNAFTATE	1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
06KB629TKV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
308a91d1-3511-4e2d-a62f-a31d77d70e06	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44577-002-01	CLARUS Antifungal	15 mL in 1 BOTTLE	SOLUTION	15		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2
SESAME OIL	INACTIVE INGREDIENT	QX10HYY4QV	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44577-002	CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS]	6	Current NDC, Legacy NDC, 1 package rows	20231106_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 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Velloryn ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	Guangdong Quadrant Ecological Technology Co., Ltd.	4e38e1f1-0466-5b91-e063-6294a90a66c4	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Daytime Antigungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3d226b-57f1-75a6-e063-6394a90a96cd	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Nighttime Antifungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3e8895-34b4-de69-e063-6294a90a5532	2026-03-30		Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	CVS Pharmacy	3380263d-ee7b-4946-a467-35a24789a901	2026-03-27	Warnings	Exact identifier application number: M005
Micro-Guard (AF)	MICONAZOLE NITRATE	Coloplast Corp	a43a94d0-fec0-470f-bdb4-535dcce6d1e0	2026-03-27	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Fresh Citrus	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d77ec6-a1d1-13dc-e063-6394a90a95f4	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Deeply Clean	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d83736-66da-abb9-e063-6294a90a3d67	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d8848c-d157-6e2c-e063-6294a90aa259	2026-03-26	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch	ANTIFUNGAL TREATMENT KIT	Beautivity LLC	4800a93b-7042-827b-e063-6294a90acd95	2026-03-25	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment	TERBINAFINE	Shenzhen Wankelai E-commerce Co., Ltd.	4dc1d7f7-e4ae-c54b-e063-6394a90aa420	2026-03-24	Warnings	Exact identifier application number: M005
Lasolex Liquid Solution	CLOTRIMAZOLE 1%	PureTek Corporation	4dc9e64d-8235-b218-e063-6394a90a0157	2026-03-24	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. Bar	TOLNAFTATE 1%	Beautivity LLC	4dbbf09b-5bc1-501b-e063-6394a90a2a9d	2026-03-23	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Cream	MICONAZOLE NITRATE 2%	Beautivity LLC	4dbc521c-2f5f-9736-e063-6294a90ad85d	2026-03-23	Warnings	Exact identifier application number: M005
seebeellar clotrimazole 1% antifungal cream	SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	4d80e551-76c2-150a-e063-6394a90a7996	2026-03-20	Warnings	Exact identifier application number: M005
Nail Fungal Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5b5c22-4781-6391-e063-6294a90a7010	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MADRID MUSE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5cecf6-c232-6cd9-e063-6394a90a03e9	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER VALENCIA VIBES	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5de4d6-4c58-f393-e063-6294a90a323a	2026-03-19	Warnings	Exact identifier application number: M005
Toenail Fungus Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5e256f-7fd5-f903-e063-6394a90a1160	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MALLORCA BREEZE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5e50de-62fd-f9e9-e063-6394a90af0bd	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MAR BELLA	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d6005d9-5d4d-033e-e063-6294a90ad36f	2026-03-19	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
06KB629TKV	TOLNAFTATE	2398-96-1	TOLNAFTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1299066	CLARUS 1 % Topical Solution	PSN	308a91d1-3511-4e2d-a62f-a31d77d70e06	6
313423	tolnaftate 1 % Topical Solution	PSN	308a91d1-3511-4e2d-a62f-a31d77d70e06	6
1299066	tolnaftate 10 MG/ML Topical Solution [Clarus]	SBD	308a91d1-3511-4e2d-a62f-a31d77d70e06	6
313423	tolnaftate 10 MG/ML Topical Solution	SCD	308a91d1-3511-4e2d-a62f-a31d77d70e06	6
1299066	Clarus 1 % Topical Solution	SY	308a91d1-3511-4e2d-a62f-a31d77d70e06	6
1299066	Clarus 10 MG/ML Topical Solution	SY	308a91d1-3511-4e2d-a62f-a31d77d70e06	6
313423	tolnaftate 1 % Topical Solution	SY	308a91d1-3511-4e2d-a62f-a31d77d70e06	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44577-002-01	44577000201	15 mL in 1 BOTTLE (44577-002-01)	15 ml	2017-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLARUS Antifungal	Clinical Therapeutic Solutions \| Pure Source, LLC	2023-11-05	HUMAN OTC DRUG LABEL	6