CLOTRIMAZOLE

Product NDC: 70795-8020
11-digit product format: 707958020
Labeler code: 70795
Product ID: 70795-8020_46d03d44-41ab-379e-e063-6394a90ab45d
Type: HUMAN OTC DRUG
Nonproprietary name: CLOTRIMAZOLE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: GRAXCELL PHARMACEUTICAL, LLC.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-12-08
Substance: CLOTRIMAZOLE
Active strength: 1 g/mL
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 · 30 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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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	70795-8020-1	`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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	1 g/mL

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5f8ca6ad-cb25-1abf-e053-2a91aa0aca99	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
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
70795-8020-1	2025-12-25	C162847	48780-1	1030e365-413c-111a-e063-dadaa90a10e2	CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%
70795-8020-1	2024-01-30	C162847	48780-1	1030e365-413c-111a-e063-dadaa90a10e2	CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70795-8020-1	CLOTRIMAZOLE	10 mL in 1 BOTTLE	SOLUTION	10		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70795-8020-1	ML - Milliliter	70795-8020	4d046d82-f5ce-4b9e-a6c6-b9bb0513c4ef	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70795-8020	CLOTRIMAZOLE SOLUTION [GRAXCELL PHARMACEUTICAL, LLC.]	13	Current NDC, Legacy NDC, 1 package rows	20211222_5f8ca6ad-cb25-1abf-e053-2a91aa0aca99.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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FIRST SHIELD	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Ever Ready First Aid	ee198aa1-ad0d-9185-e053-2a95a90a6595	2024-01-15	Warnings	Exact identifier application number: M005
Ever Ready HAND SANITIZER	ETHYL ALCOHOL	Ever Ready First Aid	ec1af7ef-3c95-9c60-e053-2a95a90acf47	2024-01-15	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ETHYL ALCOHOL	Sled Distribution, LLC	e7451738-75d5-5dc4-e053-2a95a90a7aee	2024-01-15	Warnings	Exact identifier application number: M005
Medical Super	ALCOHOL	Beijing HKKY Medical Tech. Co., Ltd.	ed2649c6-d971-4338-8745-cd0a40f7b0c2	2024-01-13	Warnings	Exact identifier application number: M005
ER Hand Sanitizer Packets	ALCOHOL	EVER READY FIRST AID	d0b6d09c-26e0-45c7-8d37-7d42143b2e31	2024-01-11	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	eeb241a3-93ee-4b74-8cbb-65713d15e7e0	2024-01-01	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	ba1dc4a4-073f-4f30-bb9c-9ed043700431	2024-01-01	Warnings	Exact identifier application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Proficient Rx LP	7c64553b-589c-4e65-a6f0-b2847bbbe8a6	2024-01-01	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with Menthol	TOLNAFTATE	Scholl's Wellness Company	dad00745-e411-35b8-e053-2a95a90a1000	2023-12-21	Warnings	Exact identifier application number: M005
TINEACIDE	TOLNAFTATE	Blaine Labs Inc.	273eb424-5dc3-40c8-9ea7-2f732cbd11c9	2023-12-21	Warnings	Exact identifier application number: M005
TERPENICOL ANTIFUNGAL	UNDECYLENIC ACID	Blaine Labs Inc.	a020334e-aac9-4ea5-a0ea-8e5b021fe2eb	2023-12-21	Warnings	Exact identifier application number: M005
TERPENICOL	UNDECYLENIC ACID	Blaine Labs Inc.	efd99ed1-07d3-4862-ae47-883f7d1c91c6	2023-12-21	Warnings	Exact identifier application number: M005
sunmark antifungal	TOLNAFTATE	A-S Medication Solutions	6f85fbb0-297c-4949-83f2-ed9a52172154	2023-12-16	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7a0ef38a-9584-4e67-ba86-c31f86da1ed0	2023-12-11	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7d284f6f-a970-49fe-b45a-d5c6c2688bc2	2023-12-11	Warnings	Exact identifier application number: M005
Hi Vetic	TOLNAFTATE	Sato Pharmaceutical Co., Ltd.	2096e241-3ed3-49cd-88c4-71db1fd2934a	2023-12-06	Warnings	Exact identifier application number: M005
Undecylenic Acid	UNDECYLENIC ACID	Chemco Corporation	7391b53f-5567-1f45-e053-2991aa0a4fce	2023-12-05	Warnings	Exact identifier application number: M005
Hi Vetic	TOLNAFTATE	Sato Pharmaceutical Co., Ltd.	be92b480-56e8-4371-adbc-40fe74f6747c	2023-12-01	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	BluePoint Laboratories	b4c4240f-f84c-ec5e-e053-2a95a90aa082	2023-11-17	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	BluePoint Laboratories	b564f971-2a9b-a605-e053-2995a90aee69	2023-11-17	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70795-8020-1	70795802001	10 mL in 1 BOTTLE (70795-8020-1)	10 ml	2017-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%	GRAXCELL PHARMACEUTICAL, LLC.	2025-12-25	HUMAN OTC DRUG LABEL	15