Fungicure

Product NDC: 52389-600
11-digit product format: 523890600
Labeler code: 52389
Product ID: 52389-600_51def52b-eaf3-ed93-e063-6294a90ac924
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: LIQUID
Route: TOPICAL
Labeler: Kobayashi Healthcare International, Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-06-05
Substance: CLOTRIMAZOLE
Active strength: 10 mg/mL
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: Fungicure
Brand name suffix: Intensive
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309370	Internal RxNorm lookup
1045620	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
1f1b413f-278e-434f-8590-4cf731663f5c	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
52389-600-60	FungicureIntensive	1 in 1 BOX	LIQUID	1		12
52389-600-60	FungicureIntensive	60 mL in 1 BOTTLE, SPRAY	LIQUID	60		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [ALVA-AMCO PHARMACAL COMPANIES, INC.]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [ALVA-AMCO PHARMACAL COMPANIES, INC.]	1
Isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [ALVA-AMCO PHARMACAL COMPANIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-600	FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20241101_1f1b413f-278e-434f-8590-4cf731663f5c.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
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309370	clotrimazole 1 % Topical Solution	PSN	1f1b413f-278e-434f-8590-4cf731663f5c	12
1045620	FungiCURE 1 % Topical Solution	PSN	1f1b413f-278e-434f-8590-4cf731663f5c	12
1045620	clotrimazole 10 MG/ML Topical Solution [Fungicure Solution]	SBD	1f1b413f-278e-434f-8590-4cf731663f5c	12
309370	clotrimazole 10 MG/ML Topical Solution	SCD	1f1b413f-278e-434f-8590-4cf731663f5c	12
309370	clotrimazole 1 % Topical Solution	SY	1f1b413f-278e-434f-8590-4cf731663f5c	12
1045620	Fungicure 1 % Topical Solution	SY	1f1b413f-278e-434f-8590-4cf731663f5c	12
1045620	Fungicure Solution 10 MG/ML Topical Solution	SY	1f1b413f-278e-434f-8590-4cf731663f5c	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-600-60	52389060060	1 BOTTLE, SPRAY in 1 BOX (52389-600-60) / 60 mL in 1 BOTTLE, SPRAY	2008-06-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fungicure Intensive	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2026-05-15	HUMAN OTC DRUG LABEL	12