Clotrimazole

Product NDC: 68927-3491
11-digit product format: 689273491
Labeler code: 68927
Product ID: 68927-3491_c61c85e2-e0b8-47e1-b02e-31a00d11138f
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: LIQUID
Route: TOPICAL
Labeler: Pedifix
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-05-05
Marketing end: 0000-00-00
Substance: CLOTRIMAZOLE
Active strength: 10 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68927-3491		I	Inactivated by FDA		2026-10-05
excluded package	package	68927-3491	68927-3491-1	I	Inactivated by FDA		2026-10-05

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68927-3491-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68927-3491-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`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	68927-3491-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68927-3491-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68927-3491-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68927-3491-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68927-3491-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68927-3491-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68927-3491-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68927-3491-1	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
68927-3491-1	2019-11-27	C162847	48780-1	9855e2a2-4239-60a7-e053-dbdaa90a05bd	Clotrimazole 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68927-3491-1	Clotrimazole	15 mL in 1 BOTTLE	LIQUID	15		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
CARTHAMUS TINCTORIUS FLOWER OIL	INACTIVE INGREDIENT	SDQ136WIM5	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
EMU OIL	INACTIVE INGREDIENT	344821WD61	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
EUCALYPTUS GLOBULUS WHOLE	INACTIVE INGREDIENT	SI1P2XF3M3	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
OLEA EUROPAEA FRUIT VOLATILE OIL	INACTIVE INGREDIENT	8E7358CX1J	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
ROSA CANINA FLOWER OIL	INACTIVE INGREDIENT	DUY7M48I1T	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	CLOTRIMAZOLE LIQUID [PEDIFIX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE LIQUID [PEDIFIX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68927-3491	CLOTRIMAZOLE LIQUID [PEDIFIX]	1	Legacy NDC, 1 package rows	20140507_55fc471c-e80c-47a0-a148-968e0b3c85ab.zip

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
309370	clotrimazole 1 % Topical Solution	PSN	55fc471c-e80c-47a0-a148-968e0b3c85ab	1
309370	clotrimazole 10 MG/ML Topical Solution	SCD	55fc471c-e80c-47a0-a148-968e0b3c85ab	1
309370	clotrimazole 1 % Topical Solution	SY	55fc471c-e80c-47a0-a148-968e0b3c85ab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68927-3491-1	68927349101	15 mL in 1 BOTTLE	15 ml	Historical