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 12 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	13a14d3c-bfce-42b5-8463-4ec69e94774e	2026-06-03	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	43cbad59-9899-ab3b-e063-6294a90a9e12	2026-06-02	Warnings	Exact identifier application number: M005
Athletes Foot Cream	CLOTRIMAZOLE	Shenzhen Miandou Technology Co.,Ltd.	53451e74-719e-9499-e063-6394a90a9e5a	2026-06-02	Warnings	Exact identifier application number: M005
Lasolex AL	MICONAZOLE NITRATE 2% ANTIFUNGAL	PureTek Corporation	534df9be-b47a-03a1-e063-6394a90a265a	2026-06-02	Warnings	Exact identifier application number: M005
Athletes Foot	MICONAZOLE NITRATE	Premier Brands of America Inc	52d0909a-f404-0af4-e063-6394a90a3d0c	2026-06-01	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	431483f6-2386-9f5c-e063-6294a90af104	2026-06-01	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Walgreens Company	3f8d45e1-54a2-a658-e063-6294a90a6cbb	2026-06-01	Warnings	Exact identifier application number: M005
Remedy Nails	UNDECYLENIC ACID	Adwill Labs Inc	4e87b76c-c430-466a-bc30-fe1785c7c660	2026-06-01	Warnings	Exact identifier application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)	TOLNAFTATE1%	Guangzhou Huixue Biotechnology Co., Ltd.	52f1f654-fba3-e90e-e063-6394a90a1df4	2026-05-29	Warnings	Exact identifier application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.	CLOTRIMAZOLE 1%	RoyceDerm LLC	52da8be4-467c-c011-e063-6294a90a166f	2026-05-28	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Jock Itch Antifungal Treatment	MICONAZOLE NITRATE	Rida LLC	2acb9027-8f20-4b77-9b45-17fe11622c7c	2026-05-27	Warnings	Exact identifier application number: M005
Quali Life ANTIFUNGAL TEA TREE	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	52b3b0df-3f62-f9bc-e063-6394a90a52b3	2026-05-26	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b51877-e04c-569e-e063-6394a90a2fc9	2026-05-26	Warnings	Exact identifier application number: M005
NAIL EXTRA STRENGTH REPAIR PEN	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b6208d-53e4-eaa0-e063-6394a90abe7a	2026-05-26	Warnings	Exact identifier application number: M005
Toenail Fungus Pen Preventative	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b6766f-948b-2602-e063-6294a90a03cf	2026-05-26	Warnings	Exact identifier application number: M005
KDMAN	TOLNAFTATE	Dongguan Youmi Trading Co., Ltd	52a4e836-2059-a49f-e063-6394a90a6556	2026-05-25	Warnings	Exact identifier application number: M005
PUTRIZEN	UNDECYLENIC ACID, TOLNAFTATE	Guangzhou Lianbiquan Biological Technology co., Ltd	52a58f24-2a11-4d34-e063-6394a90a2924	2026-05-25	Warnings	Exact identifier application number: M005
Eye CareSpray	EYELID CLEANSING SPRAY	Shenzhen Shierjie Biological Engineering Co., LTD	52aef5dd-ff33-cace-e063-6294a90a415a	2026-05-25	Warnings	Exact identifier application number: M005
Saviland PRO Extra Strength Toenail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	5250003a-8d3a-818b-e063-6294a90aa659	2026-05-21	Warnings	Exact identifier application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52506297-44d7-b2a7-e063-6394a90a0a3c	2026-05-21	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