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 27 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Myco Nail A Antifungal Solution	UNDECYLENIC ACID	Kramer Novis	550358d7-69e8-4ea3-bcf9-d647c457287d	2025-12-04	Warnings	Exact identifier application number: M005
Tea Tree Oil Antifungal Soaps	TOLNAFTATE	Nanjing Jitaxing Technology Co., LTD	4517d3a7-9144-b91d-e063-6294a90a4990	2025-12-03	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	23ca78c0-16a9-455c-99a7-b9a9a3affa60	2025-12-03	Warnings	Exact identifier application number: M005
Gembooxt Nail Fungus Solution	GEMBOOXT NAIL FUNGUS SOLUTION	Guangdong Quadrant Ecological Technology Co., Ltd.	44f5c1bc-decf-beef-e063-6394a90ab562	2025-12-02	Warnings	Exact identifier application number: M005
WELMATE Clotrimazole Topical Solution	CLOTRIMAZOLE	YYBA CORP	dc5bac4a-938c-4678-89ac-a899440c6a3c	2025-12-02	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	TOLNAFTATE	CARDINAL HEALTH 110 dba LEADER	bb14825c-518d-bfba-e053-2995a90a7889	2025-12-02	Warnings	Exact identifier application number: M005
ProCure Antifungal	MICONAZOLE NITRATE 2%	Twin Med LLC	3d375325-ddad-f1e1-e063-6394a90a679f	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	0a6cb1f7-a2a2-46a2-ae63-d205318996f0	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Miconazole Nitrate	MICONAZOLE NITRATE	New World Imports, Inc	bed775be-8bcb-44c2-9b9f-8bb25b4b2453	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Tolnaftate	TOLNAFTATE	New World Imports, Inc	cabf84c1-1500-46fe-b226-b16d4a0666c7	2025-12-01	Warnings	Exact identifier application number: M005
Trimazole	CLOTRIMAZOLE	Trifluent Pharma LLC	a3bafc52-1404-4e0b-84c1-e28bffcb091e	2025-12-01	Warnings	Exact identifier application number: M005
APUREE Pure Nailtific Extra-Strength Fungal Nail Patches	APUREE PURE NAILTIFIC EXTRA-STRENGTH FUNGAL NAIL PATCHES	Guangzhou Meixi Biotechnology Co., Ltd.	445354d8-bec2-0fd9-e063-6394a90a0099	2025-11-24	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	VALU MERCHANDISERS, CO	f4abb499-6893-9efb-e053-2995a90a33ed	2025-11-24	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE ATHLETES FOOT POWDER SPRAY TALC FREE	VALU MERCHANDISERS, CO	9ac97d4a-169b-49ff-aa34-ccb5b43726a1	2025-11-24	Warnings	Exact identifier application number: M005
Tolnafate	FOOT ODOR CONTROL POWDER SPRAY	VALU MERCHANDISERS, CO	51b69b0f-d63f-4fe0-87e6-722f95568761	2025-11-24	Warnings	Exact identifier application number: M005
Miconazole Nitrate Antifungal Powder	MICONAZOLE NITRATE ANTIFUNGAL POWDER	Marlex Pharmaceuticals, Inc.	de4f703c-39e9-855e-e053-2a95a90a6ea9	2025-11-21	Warnings	Exact identifier application number: M005
Odor-Eaters Athletes Foot	TOLNAFTATE	Blistex Inc.	20d795d1-2345-4d4f-8439-07ad11ff8f65	2025-11-21	Warnings	Exact identifier application number: M005
Derman Antifungal	ZINC UNDECYLENATE	Compania Internacional de Comercio, S.A.P.I de C.V.	0129d801-90f6-49fd-857f-27d6ba9fc66c	2025-11-19	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	9afb964c-9b88-4701-adcf-7070e25cb6c1	2025-11-19	Warnings	Exact identifier application number: M005
AU KAH CHUEN ANTIFUNGAL	CLOTRIMAZOLE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	3a262bcd-e6c0-4554-ab1c-9c861f90e190	2025-11-18	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