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 44 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr. Rainer s Vaginal Cream	MICONAZOLE NITRATE	Plexoris Health Care Products, Llc	1f0ee635-c70d-4194-a01d-370ca5c22fcd	2024-12-11	Warnings	Exact identifier application number: M005
BOA VIDA Antifungal	MICONAZOLE NITRATE	Central Solutions Inc	69c5340d-9abd-43bf-a90b-9568d615f06f	2024-12-09	Warnings	Exact identifier application number: M005
BLUESEA DISPOSABLE HAND SANITIZER	ALCOHOL	BLUE SEA AEROSOL & DAILY CARE CO., LTD	7a552be2-a9e1-4c6f-b1c2-79113a73bd2f	2024-12-06	Warnings	Exact identifier application number: M005
U HAND SANITIZER CLASSIC	BENZALKONIUM CHLORIDE	BLUE SEA AEROSOL & DAILY CARE CO., LTD	fbc27a24-0e81-4907-b24f-881c4fe0ec44	2024-12-06	Warnings	Exact identifier application number: M005
BLUESEA INSTANT HAND SANITIZER	ALCOHOL	BLUE SEA AEROSOL & DAILY CARE CO., LTD	e6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd	2024-12-06	Warnings	Exact identifier application number: M005
Povidone-Iodine	POVIDONE-IODINE	Mazza Healthcare, LLC	31df570a-35ae-41a2-b04a-fce65e9d596d	2024-11-21	Warnings	Exact identifier application number: M005
Povidone-Iodine	POVIDONE-IODINE	Mazza Healthcare, LLC	3dc3303f-54b2-4aec-8568-5e0f8eb7cb14	2024-11-21	Warnings	Exact identifier application number: M005
WINCO ANTIFUNGAL	TOLNAFTATE 1%	WinCo Foods LLC	46b58c71-d62e-4b3d-b2ec-65407032eeea	2024-11-21	Warnings	Exact identifier application number: M005
Dynarex Antifungal	ANTIFUNGAL	Dynarex Corporation	ab5b6467-c158-4407-9d52-3c0731030680	2024-11-20	Warnings	Exact identifier application number: M005
Terrasil JockItch Treatment Maximum Strength	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	8afe11c1-0a85-4255-8eba-e8cbde0759a0	2024-11-20	Warnings	Exact identifier application number: M005
Terrasil Ringworm Treatment MAX	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	fc2b740a-49c1-4a01-a94c-8cade52a2b82	2024-11-20	Warnings	Exact identifier application number: M005
MICONAZOLE NITRATE	MICONAZOLE NITRATE	ALLIED TRADE LINK LLC	25520dba-0159-2a3f-e063-6294a90a4c33	2024-11-12	Warnings	Exact identifier application number: M005
CLOTRIMAZOLE	CLOTRIMAZOLE	ALLIED TRADE LINK LLC	266d7b94-2954-4831-e063-6394a90a3f33	2024-11-08	Warnings	Exact identifier application number: M005
Antifungal	TOLNAFTATE 1%	Chain Drug Marketing Association Inc.	26303499-dc58-f417-e063-6394a90a0a1b	2024-11-05	Warnings	Exact identifier application number: M005
AZOLEN	MICONAZOLE NITRATE	STRATUS PHARMACEUTICALS INC	3264bd0a-c628-404b-8c09-8586682d054e	2024-10-31	Warnings	Exact identifier application number: M005
BACITRACIN ZINC	BACITRACIN ZINC	STRATUS PHARMACEUTICALS INC	b2cb3a96-b0ca-42ee-8056-91d5450fb376	2024-10-31	Warnings	Exact identifier application number: M005
Premier Value Antifungal Maximum Strength	UNDECYLENIC ACID	PHARMACY VALUE ALLIANCE, LLC	f5694ee5-616c-40f6-8da4-c3620dbcd6f7	2024-10-28	Warnings	Exact identifier application number: M005
Clotrimazole 1%	CLOTRIMAZOLE	Chain Drug Marketing Association Inc.	24ff5ad7-2ff9-b254-e063-6394a90a27a7	2024-10-21	Warnings	Exact identifier application number: M005
Micomitin Antifungal	TOLNAFTATE	PureTek Corporation	de9842ba-0254-8ae1-e053-2995a90a0664	2024-10-16	Warnings	Exact identifier application number: M005
Ongo - Fin	TOLNAFTATE	Efficient Laboratories Inc.	bb5fb71f-bee0-42fa-9c9f-6231b555324c	2024-10-14	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