Clotrimazole 1%

Product NDC: 69771-032
11-digit product format: 697710032
Labeler code: 69771
Product ID: 69771-032_334f174d-fe88-517d-e063-6394a90a8d4d
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: TOPICAL
Labeler: GERI-GENTLE CORPORATION
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-08-17
Substance: CLOTRIMAZOLE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69771-032-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69771-032-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69771-032-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69771-032-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69771-032-23	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69771-032-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69771-032-23	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69771-032-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69771-032-23	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69771-032-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69771-032-23	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69771-032-23	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69771-032-23	`1332a3947898…`	`d4bfe170f9cd…`

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 1%
Brand name suffix: Athletes Foot
Listing expiration: 2026-12-31

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
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
e673748f-d00b-4ce8-e053-2995a90a9220	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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69771-032-23	2025-04-21	C162847	48780-1	1030e365-3833-111a-e063-dadaa90a10e2	GG Clotrimazole USP, 1%
69771-032-23	2024-01-30	C162847	48780-1	1030e365-3833-111a-e063-dadaa90a10e2	GG Clotrimazole USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69771-032-23	Clotrimazole 1%Athletes Foot	113 g in 1 TUBE	CREAM	113		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69771-032	CLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [GERI-GENTLE CORPORATION]	2	Current NDC, Legacy NDC, 1 package rows	20250423_e673748f-d00b-4ce8-e053-2995a90a9220.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 14 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOTRIMAZOLE	CLOTRIMAZOLE	Rugby Laboratories, Inc.	2c60e631-5930-4420-886d-eb1990c720b6	2026-05-11	Warnings	Exact identifier application number: M005
Tolfyra	TOLNAFTATE	Oncora Pharma, LLC	b28ee9f2-fc45-4336-b374-be7aa51d44e9	2026-05-11	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	c0f58a0d-a304-41f9-bbdf-c2e488230cf0	2026-05-11	Warnings	Exact identifier application number: M005
Inlifay ANTIFUNGAL	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	5148b838-d26e-cf66-e063-6394a90ae469	2026-05-09	Warnings	Exact identifier application number: M005
HuiPoLii NAIL PFLASTER	TOLNAFTATE 1% NAIL PFLASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	514b1c2d-cecb-30a2-e063-6394a90af266	2026-05-08	Warnings	Exact identifier application number: M005
Recuren Plus Jock Itch Cream	MICONAZOLE NITRATE 2%	REGENEREN PLUS LTD	450dab4d-168a-60b8-e063-6394a90ab303	2026-05-08	Warnings	Exact identifier application number: M005
OSIMOON FUNGAL NAIL TREATMENT Kit	FUNGAL NAIL TREATMENT KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	51465ebf-3b5f-e2bf-e063-6394a90adaf2	2026-05-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea Antifungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	40089a7d-c893-4e90-e063-6294a90aa6f9	2026-05-06	Warnings	Exact identifier application number: M005
QQE Fungal Nail Treatment	TOLNAFTATE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	510ff705-e2cb-b77b-e063-6394a90a9e72	2026-05-05	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Akron Pharma Inc	692d7e0f-50d4-4abb-8c74-36bc98064fe7	2026-05-05	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	KJD Pharma Private Limited	5115f8e3-5668-5207-e063-6394a90a7650	2026-05-05	Warnings	Exact identifier application number: M005
NATURAL CURES FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Jiangxi Yudexi Pharmaceutical Co., LTD	510a8df7-ea6d-d634-e063-6294a90aea53	2026-05-04	Warnings	Exact identifier application number: M005
Hand Sanitizer Lemon Scented	ALCOHOL	Taizhou Juheng Biotechnology Co., Ltd.	21387234-0ac9-499d-97bf-90bccc4782ad	2026-05-04	Warnings	Exact identifier application number: M005
Uauko Fungal Nail Treatment	FUNGAL NAIL TREATMENT	Guangzhou Jingliang Cosmetics Co., Ltd.	50d16854-ab90-d6cf-e063-6294a90a21b1	2026-05-02	Warnings	Exact identifier application number: M005
NAIL RENEW	TOLNAFTATE	Nailrenew Corp	a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	2026-05-02	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEEL	ALCOHOL HAND SANITIZER SPRAY	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4934c20d-6295-aeb8-e063-6394a90adfeb	2026-04-30	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35ml	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4931f2e4-0fef-a8c7-e063-6394a90ac16e	2026-04-30	Warnings	Exact identifier application number: M005
MINADCIN TOENAIL FUNGUS PEN	UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	50a9264e-aba0-0ae2-e063-6294a90acfff	2026-04-30	Warnings	Exact identifier application number: M005
ANTIFUNGAL	UNDECYLENIC ACID	Chemco Corporation	50893584-c1c6-9ffa-e063-6394a90ae177	2026-04-29	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MIST	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	50949ae2-3ebe-08d2-e063-6394a90a2046	2026-04-29	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	e673748f-d00b-4ce8-e053-2995a90a9220	2
309367	clotrimazole 10 MG/ML Topical Cream	SCD	e673748f-d00b-4ce8-e053-2995a90a9220	2
309367	clotrimazole 1 % Topical Cream	SY	e673748f-d00b-4ce8-e053-2995a90a9220	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69771-032-23	69771003223	113 g in 1 TUBE (69771-032-23)	113 g	2022-08-17	0000-00-00	No	No	Current