Clotrimazole

Product NDC: 69396-001
11-digit product format: 693960001
Labeler code: 69396
Product ID: 69396-001_3d0eea58-f83c-2b5d-e063-6294a90a1c05
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: TOPICAL
Labeler: TRIFECTA PHARMACEUTICALS USA LLC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-03-10
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
6b74d405-42d6-4c46-ba78-3007d1e8ffb8	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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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	SPL version
69396-001-04	Clotrimazole	1 in 1 BOX	CREAM	1	24
69396-001-04	Clotrimazole	113.4 g in 1 TUBE	CREAM	113.4	24
69396-001-05	Clotrimazole	15 g in 1 TUBE	CREAM	15	24
69396-001-05	Clotrimazole	1 in 1 BOX	CREAM	1	24
69396-001-09	Clotrimazole	0.9 g in 1 PACKAGE	CREAM	0.9	24
69396-001-09	Clotrimazole	144 in 1 BOX	CREAM	144	24
69396-001-10	Clotrimazole	30 g in 1 TUBE	CREAM	30	24
69396-001-10	Clotrimazole	10 in 1 BOX	CREAM	10	24
69396-001-20	Clotrimazole	28.4 g in 1 TUBE	CREAM	28.4	24
69396-001-20	Clotrimazole	1 in 1 BOX	CREAM	1	24
69396-001-33	Clotrimazole	3 in 1 BOX	CREAM	3	24
69396-001-33	Clotrimazole	30 g in 1 TUBE	CREAM	30	24
69396-001-44	Clotrimazole	4 in 1 BOX	CREAM	4	24
69396-001-44	Clotrimazole	30 g in 1 TUBE	CREAM	30	24
69396-001-55	Clotrimazole	5 in 1 BOX	CREAM	5	24
69396-001-55	Clotrimazole	28.4 g in 1 TUBE	CREAM	28.4	24
69396-001-66	Clotrimazole	30 g in 1 TUBE	CREAM	30	24
69396-001-66	Clotrimazole	4 in 1 BOX	CREAM	4	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-001-05	GM - Gram	69396-001	0e552ddd-b14e-48ef-bc6b-2b3ad31fca8e	1	2025-01-14
69396-001-20	GM - Gram	69396-001	2dd0887e-5db0-4e7f-a99f-38477bb04dd0	1	2019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
DIMETHYL SULFOXIDE	INACTIVE INGREDIENT	YOW8V9698H	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-001	CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	22	Current NDC, Legacy NDC, 18 package rows	20250210_6b74d405-42d6-4c46-ba78-3007d1e8ffb8.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 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Velloryn ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	Guangdong Quadrant Ecological Technology Co., Ltd.	4e38e1f1-0466-5b91-e063-6294a90a66c4	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Daytime Antigungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3d226b-57f1-75a6-e063-6394a90a96cd	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Nighttime Antifungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3e8895-34b4-de69-e063-6294a90a5532	2026-03-30		Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	CVS Pharmacy	3380263d-ee7b-4946-a467-35a24789a901	2026-03-27	Warnings	Exact identifier application number: M005
Micro-Guard (AF)	MICONAZOLE NITRATE	Coloplast Corp	a43a94d0-fec0-470f-bdb4-535dcce6d1e0	2026-03-27	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Fresh Citrus	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d77ec6-a1d1-13dc-e063-6394a90a95f4	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Deeply Clean	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d83736-66da-abb9-e063-6294a90a3d67	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d8848c-d157-6e2c-e063-6294a90aa259	2026-03-26	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch	ANTIFUNGAL TREATMENT KIT	Beautivity LLC	4800a93b-7042-827b-e063-6294a90acd95	2026-03-25	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment	TERBINAFINE	Shenzhen Wankelai E-commerce Co., Ltd.	4dc1d7f7-e4ae-c54b-e063-6394a90aa420	2026-03-24	Warnings	Exact identifier application number: M005
Lasolex Liquid Solution	CLOTRIMAZOLE 1%	PureTek Corporation	4dc9e64d-8235-b218-e063-6394a90a0157	2026-03-24	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. Bar	TOLNAFTATE 1%	Beautivity LLC	4dbbf09b-5bc1-501b-e063-6394a90a2a9d	2026-03-23	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Cream	MICONAZOLE NITRATE 2%	Beautivity LLC	4dbc521c-2f5f-9736-e063-6294a90ad85d	2026-03-23	Warnings	Exact identifier application number: M005
seebeellar clotrimazole 1% antifungal cream	SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	4d80e551-76c2-150a-e063-6394a90a7996	2026-03-20	Warnings	Exact identifier application number: M005
Nail Fungal Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5b5c22-4781-6391-e063-6294a90a7010	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MADRID MUSE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5cecf6-c232-6cd9-e063-6394a90a03e9	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER VALENCIA VIBES	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5de4d6-4c58-f393-e063-6294a90a323a	2026-03-19	Warnings	Exact identifier application number: M005
Toenail Fungus Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5e256f-7fd5-f903-e063-6394a90a1160	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MALLORCA BREEZE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5e50de-62fd-f9e9-e063-6394a90af0bd	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MAR BELLA	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d6005d9-5d4d-033e-e063-6294a90ad36f	2026-03-19	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	6b74d405-42d6-4c46-ba78-3007d1e8ffb8	24
309367	clotrimazole 10 MG/ML Topical Cream	SCD	6b74d405-42d6-4c46-ba78-3007d1e8ffb8	24
309367	clotrimazole 1 % Topical Cream	SY	6b74d405-42d6-4c46-ba78-3007d1e8ffb8	24
309367	clotrimazole 1 % Topical Cream	PSN	800a9dab-d287-427e-af6d-26996e0def41	3
309367	clotrimazole 10 MG/ML Topical Cream	SCD	800a9dab-d287-427e-af6d-26996e0def41	3
309367	clotrimazole 1 % Topical Cream	SY	800a9dab-d287-427e-af6d-26996e0def41	3
309367	clotrimazole 1 % Topical Cream	PSN	0052992a-819c-4c55-bd88-201a09a3573a	1
309367	clotrimazole 10 MG/ML Topical Cream	SCD	0052992a-819c-4c55-bd88-201a09a3573a	1
309367	clotrimazole 1 % Topical Cream	SY	0052992a-819c-4c55-bd88-201a09a3573a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-001-04	69396000104	1 TUBE in 1 BOX (69396-001-04) / 113.4 g in 1 TUBE	1 tube	2022-05-03	0000-00-00	No	No	Current
69396-001-05	69396000105	1 TUBE in 1 BOX (69396-001-05) / 15 g in 1 TUBE	1 tube	2016-08-23	0000-00-00	No	No	Current
69396-001-09	69396000109	144 PACKAGE in 1 BOX (69396-001-09) / .9 g in 1 PACKAGE	144 package	2022-03-09	0000-00-00	No	No	Current
69396-001-10	69396000110	10 TUBE in 1 BOX (69396-001-10) / 30 g in 1 TUBE	10 tube	2024-07-03		No	No	Current
69396-001-20	69396000120	1 TUBE in 1 BOX (69396-001-20) / 28.4 g in 1 TUBE	1 tube	2015-03-10	0000-00-00	No	No	Current
69396-001-33	69396000133	3 TUBE in 1 BOX (69396-001-33) / 30 g in 1 TUBE	3 tube	2024-06-10		No	No	Current
69396-001-44	69396000144	4 TUBE in 1 BOX (69396-001-44) / 30 g in 1 TUBE	4 tube	2024-11-06		No	No	Current
69396-001-55	69396000155	5 TUBE in 1 BOX (69396-001-55) / 28.4 g in 1 TUBE	5 tube	2023-11-06		No	No	Current
69396-001-66	69396000166	4 TUBE in 1 BOX (69396-001-66) / 30 g in 1 TUBE	4 tube	2024-03-18		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole cream USP, 1%	TRIFECTA PHARMACEUTICALS USA LLC \| Trifecta Pharmaceuticals USA	2025-08-23	HUMAN OTC DRUG LABEL	24
Clotrimazole cream USP, 1%	Preferred Pharmaceuticals Inc.	2025-02-21	HUMAN OTC DRUG LABEL	1
Clotrimazole cream USP, 1%	Proficient Rx LP	2023-11-01	HUMAN OTC DRUG LABEL	3