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 34 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	AvPAK	3ca3b475-7b69-442a-e063-6294a90a7b3f	2025-08-18	Warnings	Exact identifier application number: M005
Formula 3	TOLNAFTATE	The Tetra Corporation	0895274b-a09d-4264-a43f-852e44eb3163	2025-08-18	Warnings	Exact identifier application number: M005
Formula 7 - The Solution	TOLNAFTATE	The Tetra Corporation	18619649-7f79-4b6e-8b7c-69d70365d557	2025-08-18	Warnings	Exact identifier application number: M005
GlyCylic	SALICYLIC ACID	The Tetra Corporation	501d3ba9-ba42-4c1c-983b-492adaee039d	2025-08-18	Warnings	Exact identifier application number: M005
SupreH Ringworm Treatment Balm	SUPREH RINGWORM TREATMENT BALM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3c77222b-d92e-84b0-e063-6294a90aadd7	2025-08-16	Warnings	Exact identifier application number: M005
OetMoe Antifungal Solution	OETMOE ANTIFUNGAL SOLUTION	Shenzhen Earth Surface Trading Co., Ltd.	3c26d917-4186-6f02-e063-6394a90a99f6	2025-08-12	Warnings	Exact identifier application number: M005
Cureforte Anti Fungal Foot Care	ANTI FUNGAL FOOT CARE DROPS	STEEL CITY HEALTH PRIVATE LIMITED	39f762a6-9d0c-8ded-e063-6394a90a3659	2025-08-11	Warnings	Exact identifier application number: M005
Derman Antifungal Powder Tolnaftate	TOLNAFTATE	Taisho Pharmaceutical California Inc.	3a854765-740c-4719-8abf-4b3f932cdee0	2025-08-07	Warnings	Exact identifier application number: M005
Derman antifungal cream	TOLNAFTATE	Taisho Pharmaceutical California Inc.	15d9b3c9-01af-4083-a1bc-014505d8798d	2025-08-07	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Hudson Health LLC	24b22794-f9f8-6f32-e063-6394a90aec98	2025-08-07	Warnings	Exact identifier application number: M005
Toe Area Treatment	TOLNAFTATE	CVS	17681cc8-fbb1-a0cf-e063-6294a90add18	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Family Dollar Services, Inc	178e7b3f-949f-3f51-e063-6294a90a9395	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	LEADER/Cardinal Health 110, Inc.	17695563-3765-74cb-e063-6294a90a6120	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Target Corporation	1dff278f-47bc-459a-e063-6394a90a2646	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	TopCo Associates	19c268a1-7b2e-63c9-e063-6394a90acddc	2025-08-07	Warnings	Exact identifier application number: M005
Antifungal Liquid Maximum Strength	TOLNAFTATE	Walgreens Company	137eabb7-cb4f-1631-e063-6294a90ab847	2025-08-07	Warnings	Exact identifier application number: M005
WCTNGO Fungal Nail Treatment Swabs	TOLNAFTATE,UNDECYLENIC ACID	Shenzhen Boyimei Technology Co., Ltd.	3bad0d73-b33d-b962-e063-6294a90a7ba7	2025-08-06	Warnings	Exact identifier application number: M005
ONIADBA Nail Fungus Treatment Pen	TOLNAFTATE,UNDECYLENIC ACID	Shenzhen Boyimei Technology Co., Ltd.	3bad19f1-d5b3-c5de-e063-6294a90a0c03	2025-08-06	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Premier Brands of America Inc	2644ba07-aaee-6402-e063-6394a90a2827	2025-08-06	Warnings	Exact identifier application number: M005
Anti- Fungal Miconazole Nitrate	MICONAZOLE NITRATE	Premier Brands of America Inc.	f186bdc1-db6c-0fab-e053-2995a90a7c58	2025-08-06	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