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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnaftate	TOLNAFTATE	Sheffield Pharmaceuticals LLC	ca52af37-c3a2-414c-a24a-a37a92925133	2025-02-20	Warnings	Exact identifier application number: M005
Dr Sheffield Athletes Foot	CLOTRIMAZOLE	Sheffield Pharmaceuticals LLC	b8b8e6b2-1022-4592-91ba-3cf94c7cf318	2025-02-19	Warnings	Exact identifier application number: M005
UKVOA Toenail Fungus Treatment	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2e3cde7b-850e-f9d2-e063-6394a90adb18	2025-02-16	Warnings	Exact identifier application number: M005
UKOVA FOOT ODOR PROBIOTIC	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2de0225d-dd85-e2da-e063-6294a90a050b	2025-02-11	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes Foot Wipes	TOLNAFTATE	Cosco International, Inc.	cde656a9-7841-4a73-a2f4-f5a76a3e15c1	2025-02-06	Warnings	Exact identifier application number: M005
Silka Athletes Foot	MICONAZOLE NITRATE	Genomma Lab USA	307104a2-2df6-43b0-bf3f-f4d93d3e40f1	2025-02-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	fd7dd2eb-03a7-ef1f-e053-6294a90a8557	2025-02-04	Warnings	Exact identifier application number: M005
Molecular AF	TOLNAFTATE	Renu Laboratories, LLC	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	2025-02-03	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Papalo Group LLC	2d2c0e12-123d-75bd-e063-6394a90ae546	2025-01-31	Warnings	Exact identifier application number: M005
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	IDO PHARM	d5833c6f-81dd-6ff6-e053-2995a90ac76d	2025-01-30	Warnings	Exact identifier application number: M005
AWAS ALCOHOLSPRAY	ALCOHOL	IDO PHARM	03010837-0289-3e08-e063-6394a90a7d04	2025-01-30	Warnings	Exact identifier application number: M005
ELON Dual Defense Anti Fungal Formula	UNDECYLENIC ACID	Little Giant Holdings LLC	45c4567d-7876-6459-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M005
DCH Labs Antifungal Jock	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	fc749882-2e1e-cad3-e053-6294a90a33ca	2025-01-27	Warnings	Exact identifier application number: M005
Antifungal Pen	UNDECYLENIC ACID 25%	XF Agencija Limited	a15d4512-0fc6-424f-9dd3-ab433d9b7a26	2025-01-27	Warnings	Exact identifier application number: M005
Mata Hongos	UNDECYLENIC ACID	Vitamex USA, Corp	21ca7edb-dde3-5846-e063-6394a90a3cc0	2025-01-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	53cb4c0d-40b5-4cf3-b122-fd6dd654883f	2025-01-23	Warnings	Exact identifier application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGAL	TOLNAFTATE	Natureplex, LLC	575b8645-9166-4242-a74f-f4aa4acaaf3d	2025-01-15	Warnings	Exact identifier application number: M005
Tobcharm Antifungal Treatment Cream	ANTIFUNGAL TREATMENT CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba241cc-2767-1190-e063-6294a90ac66b	2025-01-13	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2%	MICONAZOLE NITRATE	Akron Pharma Inc.	8933f939-098a-4257-8d9c-4d5c3240e9a6	2025-01-10	Warnings	Exact identifier application number: M005
ANTI-ITCH FEMININE CARE	HYDROCORTISONE 0.5%	OL PHARMA TECH, LLC Drs PHARMACY	d6fa5ff3-ebdc-222d-e053-2a95a90a88d5	2025-01-09	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