Tinea Versicolor Treatment Bar

Product NDC: 85398-003
11-digit product format: 853980003
Labeler code: 85398
Product ID: 85398-003_5566dc99-c9b2-82de-e063-6294a90a45e5
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: SOAP
Route: TOPICAL
Labeler: Beautivity LLC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-05-12
Substance: CLOTRIMAZOLE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Tinea Versicolor Treatment Bar
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G07GZ97H65	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
251267	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
33612382-2f12-e9f6-e063-6394a90aaee4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85398-003-01	Tinea Versicolor Treatment Kit	116 g in 1 CARTON	SOAP	116 g	1 g in 100g	2
85398-003-01	Tinea Versicolor Treatment Bar	116 g in 1 CARTON	SOAP	116		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85398-003	TINEA VERSICOLOR TREATMENT BAR (CLOTRIMAZOLE) SOAP [BEAUTIVITY LLC]	1	Current NDC, 1 package rows	20250513_33612382-2f12-e9f6-e063-6394a90aaee4.zip
85398-003	TINEA VERSICOLOR TREATMENT KIT (CLOTRIMAZOLE) KIT [BEAUTIVITY LLC]	1	Current NDC	20250515_3361d9a2-daf6-7749-e063-6294a90a3653.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 10 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Beilloso Hyaluronic Acid	CLOTRIMAZOLE 1 PERCENT HYALURONIC ACID	Jiangxi Yudexi Pharmaceutical Co., LTD	4a712797-c992-dd8e-e063-6294a90a0592	2026-06-14	Warnings	Exact identifier application number: M005
Beilloso Balanitis Relief	MICONAZOLE NITRATE 2% BALANITIS RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4a71c26f-dee5-7b7f-e063-6294a90afcc1	2026-06-14	Warnings	Exact identifier application number: M005
PUVIDA FUNGAL NAIL	TOLNAFTATE 1% FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4c55fcad-c59f-9a6e-e063-6394a90a6c5f	2026-06-14	Warnings	Exact identifier application number: M005
Klipp EXTRA STRENGTH TOENAIL FUNGUS TREATMENT	KLIPP EXTRA STRENGTH TOENAIL FUNGUS TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	54430f20-72db-64f7-e063-6394a90a2cc3	2026-06-14	Warnings	Exact identifier application number: M005
Bldaxn FUNGAL NAIL RENEWZL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWZL	Jiangxi Yudexi Pharmaceutical Co., LTD	4993181e-68d5-6b91-e063-6294a90a65ce	2026-06-12	Warnings	Exact identifier application number: M005
NATUHEAL MULTI -PURPOSE TREATMENT	TOLNAFTATE 1% MULTI -PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a469862-85ab-4c24-e063-6294a90ad245	2026-06-12	Warnings	Exact identifier application number: M005
cmojsk TOENAIL FUNGUS PEN	UNDECYLENIC ACID 25% TOLNAFTATE 1% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	524bbb36-df7b-f21a-e063-6394a90ad0f1	2026-06-12	Warnings	Exact identifier application number: M005
BODYKOO NAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25% NAIL FUNGUS TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	535191e9-dc55-0c60-e063-6394a90a330f	2026-06-12	Warnings	Exact identifier application number: M005
Charmpoo Antifungal Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	5214a267-0bab-59b8-e063-6394a90adb84	2026-06-12	Warnings	Exact identifier application number: M005
EVERFERE ANTIFUNGAL	UNDECYLENIC ACID 10% ZINC UNDECYLENATE 12% ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4bc99af7-ea08-8543-e063-6294a90a44cd	2026-06-12	Warnings	Exact identifier application number: M005
nail fungus treatment	TOLNAFTATE	Guangzhou Liyan Cosmetics Technology Co., Ltd.	54ee5e53-8c99-01f8-e063-6394a90ae382	2026-06-12	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Soap.	TOLNAFTATE 1%	Trovina Co. Ltd	514fc45c-aadb-6205-e063-6394a90ae473	2026-06-11	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	53fed66b-a371-38d2-e063-6294a90a510e	2026-06-11	Warnings	Exact identifier application number: M005
SEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASH	SEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASH	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	54050e6b-a7f1-5067-e063-6394a90aebe5	2026-06-11	Warnings	Exact identifier application number: M005
Velloryn 1% Clotrimazole ANTIFUNGAL	VELLORYN 1% CLOTRIMAZOLE ANTIFUNGAL	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	540652da-f8f0-01ee-e063-6294a90a12e9	2026-06-11	Warnings	Exact identifier application number: M005
Fitcube NAIL REPAIR PEN	UNDECYLENIC ACID 25% TOLNAFTATE 1% NAIL REPAIR PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	5365268e-7845-4a91-e063-6294a90ac6bf	2026-06-10	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Walgreens Company	3858402f-783b-9292-e063-6294a90abe38	2026-06-10	Warnings	Exact identifier application number: M005
Hermon Antifungal cleansing bar	TOLNAFTATE 1%	Beautivity LLC	53cd1a2b-6ca6-c93b-e063-6394a90aaf3a	2026-06-09	Warnings	Exact identifier application number: M005
Antifungal 1% Clotrimazole Cream	ANTIFUNGAL 1% CLOTRIMAZOLE CREAM	Twincraft Inc.	29698d9e-8449-ceee-e063-6394a90a366e	2026-06-09	Warnings	Exact identifier application number: M005
Antifungal 1% Clotrimazole Cream	ANTIFUNGAL 1% CLOTRIMAZOLE CREAM	Defense Soap LLC	040264b2-8f2f-f059-e063-6294a90ad720	2026-06-09	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
251267	clotrimazole 1 % Medicated Bar Soap	PSN	33612382-2f12-e9f6-e063-6394a90aaee4	2
251267	clotrimazole 1 % Medicated Bar Soap	PSN	3361d9a2-daf6-7749-e063-6294a90a3653	2
309367	clotrimazole 1 % Topical Cream	PSN	3361d9a2-daf6-7749-e063-6294a90a3653	2
251267	clotrimazole 0.01 MG/MG Medicated Bar Soap	SCD	33612382-2f12-e9f6-e063-6394a90aaee4	2
251267	clotrimazole 0.01 MG/MG Medicated Bar Soap	SCD	3361d9a2-daf6-7749-e063-6294a90a3653	2
309367	clotrimazole 10 MG/ML Topical Cream	SCD	3361d9a2-daf6-7749-e063-6294a90a3653	2
251267	clotrimazole 1 % Medicated Bar Soap	SY	33612382-2f12-e9f6-e063-6394a90aaee4	2
251267	clotrimazole 1 % Medicated Bar Soap	SY	3361d9a2-daf6-7749-e063-6294a90a3653	2
309367	clotrimazole 1 % Topical Cream	SY	3361d9a2-daf6-7749-e063-6294a90a3653	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85398-003-01	85398000301	116 g in 1 CARTON (85398-003-01)	116 g	2025-05-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Update-85398-003-01	Beautivity LLC	2026-06-29	HUMAN OTC DRUG LABEL	3
Update-85398-004-01	Beautivity LLC	2026-06-29	HUMAN OTC DRUG LABEL	3