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 43 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	DRS. CLOTRIMAZOLE	OL PHARMA TECH,LLC	b0e9fc77-6d5c-2472-e053-2995a90a3de4	2025-01-09	Warnings	Exact identifier application number: M005
Anti-Bacterial Wipes	BENZALKONIUM CHLORIDE	Tongling Jieya Biological Technology Co., Ltd.	d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d	2025-01-04	Warnings	Exact identifier application number: M005
AVON HeXashield Athletes Foot Cream	TOLNAFTATE	Tai Guk Pharm. Co., Ltd.	8f2b6a09-8cb0-0d17-e053-2995a90aa07f	2025-01-01	Warnings	Exact identifier application number: M005
Tolnaftate	TOLNAFTATE 1%	Trifecta Pharmaceuticals USA, LLC	091b907f-544a-86c9-e063-6294a90a5d87	2024-12-31	Warnings	Exact identifier application number: M005
terrasil Fungal Treatment	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	278290f9-be14-81a8-e063-6294a90ad8cc	2024-12-26	Warnings	Exact identifier application number: M005
DEO PEDICO ABOVE NEYMAR JR MEN	DEO PEDICO ABOVE NEYMAR JR MEN	BASTON INDUSTRIA DE AEROSSOIS LTDA	ed4a9844-f20b-da5d-e053-2995a90adc09	2024-12-26	Warnings	Exact identifier application number: M005
Vite20	MICONAZOLE NITRATE	Blaine Labs Inc.	28a8d0dd-aab9-44ff-bab6-7ec4b5036a71	2024-12-24	Warnings	Exact identifier application number: M005
Vite20	UNDECYLENIC ACID	Blaine Labs Inc.	18f8ea1c-360e-43c0-98df-5816af4dec66	2024-12-24	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	FAMILY WELLNESS TOLNAFTATE	Trifecta Pharmaceuticals USA, LLC	915759af-0d7f-6a87-e053-2a95a90acbd6	2024-12-20	Warnings	Exact identifier application number: M005
Rugby Clotrimazole Antifungal Cream	CLOTRIMAZOLE	Rugby Laboratories	a1365bc7-b376-adca-e053-2a95a90acf19	2024-12-20	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL MICONAZOLE POWDER SPRAY	Premier Brands of America Inc.	dc7a23bb-b246-89b1-e053-2995a90a9f2d	2024-12-20	Warnings	Exact identifier application number: M005
Warrior Antifungal Foot	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	cf2e9dc1-275b-4454-e053-2995a90af295	2024-12-20	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1%	TOLNAFTATE	Pharmacy Value Alliance, LLC.	3abfd734-229b-1a0e-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Derma Care Research Labs, LLC	fbc1a55e-b994-4962-e053-6394a90a13ba	2024-12-19	Warnings	Exact identifier application number: M005
Novonail Solution	TOLNAFTATE 1%	Derma Care Research Labs, LLC	013d6107-e3b0-0264-e063-6394a90ae1e2	2024-12-19	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Rugby	f420de00-408f-9a2c-e053-2995a90adced	2024-12-17	Warnings	Exact identifier application number: M005
Relispray Antifungal Liquid	TOLNAFTATE	Midas-Care Pharmaceuticals Pvt. Ltd.	6522ad59-f810-408c-a9f9-9359d79302ce	2024-12-17	Warnings	Exact identifier application number: M005
Clotrimazole	FAMILY WELLNESS CLOTRIMAZOLE	Trifecta Pharmaceuticals USA LLC	915759af-0d7b-6a87-e053-2a95a90acbd6	2024-12-13	Warnings	Exact identifier application number: M005
Blistex Odor-Eaters Powder	TOLNAFTATE	Blistex Inc	819edb2f-dda7-45c3-b0da-ebcae354154e	2024-12-12	Warnings	Exact identifier application number: M005
Walgreens Athletes Foot	TOLNAFTATE SPRAY	Walgreens	c68ad65d-b016-0069-e053-2995a90ae7ef	2024-12-11	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