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
Ingredient	Strength
TOLNAFTATE	1 g/100g

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
103951	Internal RxNorm lookup
1299059	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
7e8897ff-67d1-4336-866e-cb76a36edddc	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44577-001-01	CLARUS Antifungal	45 g in 1 TUBE	CREAM	45		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
UREA	INACTIVE INGREDIENT	8W8T17847W	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44577-001	CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	6	Current NDC, Legacy NDC, 1 package rows	20231106_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 6 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUNGAL NAIL TREATMENT kit .liquid.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c93390-ee07-4f78-e063-6394a90add42	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit .cream.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c9d9fa-09ad-e26a-e063-6394a90a0ed9	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56cb7085-87d8-4273-e063-6394a90ac5df	2026-07-17	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL FOOT CARE	TOLNAFTATE 1% ANTIFUNGAL FOOT CARE	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b10492-894c-33e1-e063-6394a90a8c0f	2026-07-17	Warnings	Exact identifier application number: M005
Foot Choice-Nail Fungal Pen	UNDECYLENIC ACID	Foot Choice LLC	4b0036a6-8751-4f44-b6b1-5be57fa92cdc	2026-07-17	Warnings	Exact identifier application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream	2% MICONAZOLE NITRATE ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56b54359-db21-b8b4-e063-6394a90a6f8c	2026-07-16	Warnings	Exact identifier application number: M005
DRAVYNOR BALANITIS RELIEF Cream	MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b76a52-0743-4fe6-e063-6294a90a98a8	2026-07-16	Warnings	Exact identifier application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream	5% BENZOYL PEROXIDE FOLLICULITIS CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56c558fa-303f-fc52-e063-6394a90a72f0	2026-07-16	Warnings	Exact identifier application number: M005
Antifungal Ringworm Treatment Cream	MICONAZOLE NITRATE	Yunqi Cosmetics (Shenzhen) Co., Ltd	56a2ceea-c4c0-c30c-e063-6394a90a0e6a	2026-07-15	Warnings	Exact identifier application number: M005
Medi-First Antifungal Cream Miconazole Cream	MICONAZOLE	Unifirst First Aid Corporation	56a51b75-9c23-bcd2-e063-6394a90a9b12	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Tinea Treatment	CLEAR ROOT LABS TINEA TREATMENT	Aidance Scientic Inc., DBA Aidance Skincare & Topicals	56a67bad-c677-d3b7-e063-6394a90ad205	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Antifungal Treatment	CLEAR ROOT LABS ANTIFUNGAL TREATMENT	Aidance Scientific, Inc., DBA Aidance Skincare & Topicals	5696bf23-230a-5f37-e063-6294a90a7413	2026-07-15	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL NAIL Liquid	TOLNAFTATE 1% ANTIFUNGAL NAIL LIQUID	Jiangxi Yudexi Pharmaceutical Co., LTD	56b17e50-bff1-5eb0-e063-6294a90a3c08	2026-07-15	Warnings	Exact identifier application number: M005
terrasil Antifungal Cleansing Bar	CLOTRIMAZOLE	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	10a4fde0-87e1-4474-bcb5-255b0a7f1ecb	2026-07-14	Warnings	Exact identifier application number: M005
OAKDOLCHE Tea Tree Oil Antifungal	TOLNAFTATE	Nanjing Qiaotun Technology Co., Ltd.	569dee15-e68d-220e-e063-6294a90af7c5	2026-07-14	Warnings	Exact identifier application number: M005
Kimtara Nail Fungus Treatment	KIMTARA NAIL FUNGUS TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5678e260-10c4-f203-e063-6294a90a6223	2026-07-13	Warnings	Exact identifier application number: M005
Aiilo NAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25%	Guangzhou Huixue Biotechnology Co., Ltd.	5689ac31-4d23-0fcc-e063-6394a90ac75b	2026-07-13		Exact identifier application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PEN	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56519b25-f3c8-bcac-e063-6394a90af879	2026-07-11	Warnings	Exact identifier application number: M005
Joymeey FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5652a22e-7b43-3c31-e063-6294a90ae4f1	2026-07-11	Warnings	Exact identifier application number: M005
iBeaLee Nail Repair Pen	IBEALEE NAIL REPAIR PEN	Shenzhen Earth Surface Trading Co., Ltd.	564dc711-7fe2-7a8d-e063-6294a90aac26	2026-07-10	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
1299059	Clarus 1 % Topical Cream	PSN	7e8897ff-67d1-4336-866e-cb76a36edddc	6
103951	tolnaftate 1 % Topical Cream	PSN	7e8897ff-67d1-4336-866e-cb76a36edddc	6
1299059	tolnaftate 10 MG/ML Topical Cream [Clarus]	SBD	7e8897ff-67d1-4336-866e-cb76a36edddc	6
103951	tolnaftate 10 MG/ML Topical Cream	SCD	7e8897ff-67d1-4336-866e-cb76a36edddc	6
1299059	Clarus 1 % Topical Cream	SY	7e8897ff-67d1-4336-866e-cb76a36edddc	6
1299059	Clarus 10 MG/ML Topical Cream	SY	7e8897ff-67d1-4336-866e-cb76a36edddc	6
103951	tolnaftate 1 % Topical Cream	SY	7e8897ff-67d1-4336-866e-cb76a36edddc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44577-001-01	44577000101	45 g in 1 TUBE (44577-001-01)	45 g	2017-02-05	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