CLARUS Antifungal

Product NDC: 44577-001
Requested package NDC: 44577-001-01
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

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 1 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LUCKSKY Fungal Nail Renewal	UNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57a73b60-bbac-97e6-e063-6294a90ab9a9	2026-07-28	Warnings	Exact identifier application number: M005
Ponamfo ANTIFUNGAL TREATMENT PEN	UNDECYLENIC	Guangzhou Bixiaoyu Trading Co., Ltd.	57a9ccff-270b-9769-e063-6394a90a5e0c	2026-07-28	Warnings	Exact identifier application number: M005
FUNGAL NAIL PATCHES	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	5240412c-4257-8e9d-e063-6394a90a0a12	2026-07-28	Warnings	Exact identifier application number: M005
FFPMAM Antifungal Cream	FFPMAM ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	57b7cf61-d4cd-53f7-e063-6394a90afc54	2026-07-28	Warnings	Exact identifier application number: M005
Youggle WART REMOVER	SALICYLIC ACID	Guangzhou Huixue Biotechnology Co., Ltd.	57a3744e-316c-8a3d-e063-6294a90a15d1	2026-07-27	Warnings	Exact identifier application number: M005
antifungal pen	ANTIFUNGAL PEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5756256e-ed2b-4e13-e063-6294a90a1e0f	2026-07-24	Warnings	Exact identifier application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PEN	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	4d59116a-bcd0-9ed4-e063-6394a90a6dbd	2026-07-24	Warnings	Exact identifier application number: M005
SERYNTH MULTI-PURPOSE FUNCUS	TOLNAFTATE 1% MULTI-PURPOSE FUNCUS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a6ea0c9-1495-8ede-e063-6294a90ad093	2026-07-23	Warnings	Exact identifier application number: M005
HELPS WITH NAGELPILZ	TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID	Shanghai Honghui Chuang Intelligent Technology Co., Ltd	55753a4a-a4d0-a183-e063-6394a90acf11	2026-07-22	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL Oil	UNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4ff57d2d-5e74-a995-e063-6394a90a3f9a	2026-07-21	Warnings	Exact identifier application number: M005
WERPEKA FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4f7a8273-b7af-d532-e063-6394a90aa63a	2026-07-21	Warnings	Exact identifier application number: M005
HTRCSW FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	523bc484-511c-b603-e063-6394a90a55ae	2026-07-21	Warnings	Exact identifier application number: M005
DERMFREE Clotrimazole	CLOTRIMAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	49ab5abb-d311-505d-e063-6294a90a5616	2026-07-21	Warnings	Exact identifier application number: M005
DERMFREE FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	49aba00d-9249-b403-e063-6394a90a787d	2026-07-21	Warnings	Exact identifier application number: M005
SKAPEMED SKIN REPAIR	TOLNAFTATE 1% SKIN REPAIR	Jiangxi Yudexi Pharmaceutical Co., LTD	4a20c32e-0551-aead-e063-6394a90a2aa7	2026-07-21	Warnings	Exact identifier application number: M005
REINREUDE MULTI-PURPOSE TREATMENT	TOLNAFTATE 1% MULTI-PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a380945-9235-783a-e063-6294a90a094d	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH Multi-Purpose Nail Solution	TOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTION	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4af770-2bba-52a8-e063-6294a90ac287	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH Clotrimazole	CLOTRIMAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4b304a-1acc-9185-e063-6394a90a1176	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c6b7a-3c3e-1510-e063-6294a90a409a	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH HELPS WITH FUNGAL NAIL	TOLNAFTATE 1% HELPS WITH FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c9ad1-e652-2b3b-e063-6394a90a2935	2026-07-21	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