Clotrimazole

Product NDC: 51672-2002
Requested package NDC: 51672-2002-2
11-digit product format: 516722002
Labeler code: 51672
Product ID: 51672-2002_390cee55-c38f-accf-e063-6294a90ab7f7
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1995-06-01
Substance: CLOTRIMAZOLE
Active strength: 1 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
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: Clotrimazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	1 g/100g

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
309367	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
a3a5cbf5-cabb-48d8-8877-74a97f7c0f57	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-2002-1	Clotrimazole	15 g in 1 TUBE	CREAM	15	4
51672-2002-1	Clotrimazole	1 in 1 CARTON	CREAM	1	4
51672-2002-2	Clotrimazole	30 g in 1 TUBE	CREAM	30	4
51672-2002-2	Clotrimazole	1 in 1 CARTON	CREAM	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2002-1	GM - Gram	51672-2002	4c2e5eee-4d44-4728-9055-74c57d453259	1	2012-07-24
51672-2002-2	GM - Gram	51672-2002	88f9179a-bac8-4b62-817d-35adddf30d70	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
cetyl esters wax	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
cetyl esters wax	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
cetyl esters wax	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
cetyl esters wax	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2002	CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 4 package rows	20241115_a3a5cbf5-cabb-48d8-8877-74a97f7c0f57.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 7 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
EZBIORT 1% Tolnaftate Nail Essence with Biotin	TOLNAFTATE	Guangzhou Borderless Technology Co., Ltd.	5629df38-1079-be4f-e063-6394a90a1c6a	2026-07-09	Warnings	Exact identifier application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal Pen	UNDECYLENIC ACID 25% ANTIFUNGAL PEN	Shenzhen Xituo Electronics Co., Ltd	563a6704-f662-3f08-e063-6394a90a4369	2026-07-09	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	Preferred Pharmaceuticals Inc.	c6098653-351a-449f-9b1a-0c617074f2b9	2026-07-08	Warnings	Exact identifier application number: M005
YEARCHOICE Fungal Nail Renewal	FUNGAL NAIL RENEWAL	Guangzhou Jingliang Cosmetics Co., Ltd.	561b650d-028c-687c-e063-6394a90a166a	2026-07-08	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	561d3e64-ab9c-1074-e063-6394a90a1298	2026-07-08	Warnings	Exact identifier application number: M005
Beautifier Life ALCOHOL WIPES	BEAUTIFIER LIFE ALCOHOL WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	323ef469-e37c-00ad-e063-6394a90ab6f7	2026-07-08	Warnings	Exact identifier application number: M005
Folliculitis Treatment Cream	MICONAZOLE NITRATE 2%	Guangxi Keyun E-commerce Co., Ltd.	5625652a-193d-0318-e063-6294a90a56f3	2026-07-08	Warnings	Exact identifier application number: M005
Cysndra Ringworm Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangzhou Xinhongda Trading Service Co., Ltd.	55ed83eb-0e67-e516-e063-6394a90af443	2026-07-06	Warnings	Exact identifier application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial Kit	FUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KIT	PureWellness LLC	25db8c55-0fa9-4795-8e05-4d3a7aaf0148	2026-07-06	Warnings	Exact identifier application number: M005
Cysndra Fungal Nail Revitalizer	UNDECYLENIC ACID	Guangzhou Xinhongda Trading Service Co., Ltd.	55e9f1cf-4055-6c27-e063-6394a90ac373	2026-07-05	Warnings	Exact identifier application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	3b9ab6e0-8773-f909-e063-6394a90ac1c9	2026-07-03	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT	25% UNDECYLENIC ACID	100 KARMA INC	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Toenail Fungus Treatment Kit	TOENAIL FUNGUS TREATMENT	100 KARMA INC	3d4bbc65-955f-8fd8-e063-6294a90adc44	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Nailtonic Repair Pens	25% UNDECYLENIC ACID	100 KARMA INC	4a9c32b3-e78d-3c85-e063-6394a90a7bf2	2026-07-03	Warnings	Exact identifier application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	48e377b4-abb1-34cf-e063-6294a90a2ea3	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.	25% UNDECYLENIC ACID AND TOLNAFTATE 1%	100 KARMA INC	4c197131-9ca8-6024-e063-6294a90aa9cb	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Antifungal Pen	25% UNDECYLENIC ACID	100 KARMA INC	52d89172-e8a7-70c0-e063-6294a90a3563	2026-07-03	Warnings	Exact identifier application number: M005
FUNGINIX ANTI-FUNGAL TREATMENT	UNDECYLENIC ACID	The Sisquoc Healthcare Corporation	92db5433-5a1b-4cb9-b8eb-217c2a807a99	2026-07-02	Warnings	Exact identifier application number: M005
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	4cfe234c-49c0-18e8-e063-6294a90a0b1d	2026-07-02	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
309367	clotrimazole 1 % Topical Cream	PSN	1e7e74f6-9bca-48ab-804a-a7a81df3b608	7
309367	clotrimazole 1 % Topical Cream	PSN	9afb964c-9b88-4701-adcf-7070e25cb6c1	7
309367	clotrimazole 10 MG/ML Topical Cream	SCD	1e7e74f6-9bca-48ab-804a-a7a81df3b608	7
309367	clotrimazole 10 MG/ML Topical Cream	SCD	9afb964c-9b88-4701-adcf-7070e25cb6c1	7
309367	clotrimazole 1 % Topical Cream	SY	1e7e74f6-9bca-48ab-804a-a7a81df3b608	7
309367	clotrimazole 1 % Topical Cream	SY	9afb964c-9b88-4701-adcf-7070e25cb6c1	7
309367	clotrimazole 1 % Topical Cream	PSN	ba1dc4a4-073f-4f30-bb9c-9ed043700431	6
309367	clotrimazole 10 MG/ML Topical Cream	SCD	ba1dc4a4-073f-4f30-bb9c-9ed043700431	6
309367	clotrimazole 1 % Topical Cream	SY	ba1dc4a4-073f-4f30-bb9c-9ed043700431	6
309367	clotrimazole 1 % Topical Cream	PSN	70e1efac-1738-43db-b19c-bbe02810b6e7	5
309367	clotrimazole 10 MG/ML Topical Cream	SCD	70e1efac-1738-43db-b19c-bbe02810b6e7	5
309367	clotrimazole 1 % Topical Cream	SY	70e1efac-1738-43db-b19c-bbe02810b6e7	5
309367	clotrimazole 1 % Topical Cream	PSN	a3a5cbf5-cabb-48d8-8877-74a97f7c0f57	4
309367	clotrimazole 10 MG/ML Topical Cream	SCD	a3a5cbf5-cabb-48d8-8877-74a97f7c0f57	4
309367	clotrimazole 1 % Topical Cream	SY	a3a5cbf5-cabb-48d8-8877-74a97f7c0f57	4
309367	clotrimazole 1 % Topical Cream	PSN	b69db78b-5f10-8ca2-e053-2a95a90ac88c	2
309367	clotrimazole 1 % Topical Cream	PSN	01b1b76f-0c11-437f-82b5-931670c27a8d	2
309367	clotrimazole 10 MG/ML Topical Cream	SCD	b69db78b-5f10-8ca2-e053-2a95a90ac88c	2
309367	clotrimazole 10 MG/ML Topical Cream	SCD	01b1b76f-0c11-437f-82b5-931670c27a8d	2
309367	clotrimazole 1 % Topical Cream	SY	b69db78b-5f10-8ca2-e053-2a95a90ac88c	2
309367	clotrimazole 1 % Topical Cream	SY	01b1b76f-0c11-437f-82b5-931670c27a8d	2
309367	clotrimazole 1 % Topical Cream	PSN	8fcf70e8-70e2-4b41-99c0-a351b2c3a2a0	1
309367	clotrimazole 1 % Topical Cream	PSN	8e1058cf-1bd4-4c81-81a5-3a1754caca3f	1
309367	clotrimazole 1 % Topical Cream	PSN	deaa88bc-f7b0-16e2-e053-2995a90ac45a	1
309367	clotrimazole 10 MG/ML Topical Cream	SCD	8fcf70e8-70e2-4b41-99c0-a351b2c3a2a0	1
309367	clotrimazole 10 MG/ML Topical Cream	SCD	8e1058cf-1bd4-4c81-81a5-3a1754caca3f	1
309367	clotrimazole 10 MG/ML Topical Cream	SCD	deaa88bc-f7b0-16e2-e053-2995a90ac45a	1
309367	clotrimazole 1 % Topical Cream	SY	8fcf70e8-70e2-4b41-99c0-a351b2c3a2a0	1
309367	clotrimazole 1 % Topical Cream	SY	8e1058cf-1bd4-4c81-81a5-3a1754caca3f	1
309367	clotrimazole 1 % Topical Cream	SY	deaa88bc-f7b0-16e2-e053-2995a90ac45a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2002-2	51672200202	1 TUBE in 1 CARTON (51672-2002-2) / 30 g in 1 TUBE	1 tube	1995-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole Cream USP,1% Antifungal Cream	Preferred Pharmaceuticals Inc.	2026-04-01	HUMAN OTC DRUG LABEL	5
Clotrimazole Cream USP,1% Antifungal Cream	A-S Medication Solutions	2025-12-05	HUMAN OTC DRUG LABEL	7
Clotrimazole Cream USP,1% Antifungal Cream	A-S Medication Solutions	2025-11-19	HUMAN OTC DRUG LABEL	7
Clotrimazole Cream USP,1% Antifungal Cream	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-03	HUMAN OTC DRUG LABEL	4
Clotrimazole Cream USP,1% Antifungal Cream	A-S Medication Solutions	2025-01-22	HUMAN OTC DRUG LABEL	3
Clotrimazole Cream USP,1% Antifungal Cream	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	6
Clotrimazole Cream USP,1% Antifungal Cream	NuCare Pharmaceuticals,Inc.	2022-05-10	HUMAN OTC DRUG LABEL	1
Clotrimazole Cream USP,1% Antifungal Cream	REMEDYREPACK INC.	2022-03-25	HUMAN OTC DRUG LABEL	1
Clotrimazole Cream USP,1% Antifungal Cream	NuCare Pharmaceuticals,Inc.	2022-01-14	HUMAN OTC DRUG LABEL	2
Clotrimazole Cream USP,1% Antifungal Cream	Central Texas Community Health Centers \| Travis County Healthcare District	2018-06-07	HUMAN OTC DRUG LABEL	2
Clotrimazole Cream USP,1% Antifungal Cream	H.J. Harkins Company, Inc. \| Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceuticals Inc.	2011-10-14	HUMAN OTC DRUG LABEL	1
Clotrimazole Cream USP,1% Antifungal Cream	Rebel Distributors Corp	2011-02-09	HUMAN OTC DRUG LABEL	1