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 2 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Viachs ANTIFUNGAL Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	598b7e0c-c76d-2f56-e063-6394a90a7053	2026-08-21	Warnings	Exact identifier application number: M005
BlissCare tea tree oil antifungal	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	58f9ff8c-d75a-ad1d-e063-6294a90af3dc	2026-08-21	Warnings	Exact identifier application number: M005
GPPEE TOENAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25%	Guangzhou Huixue Biotechnology Co., Ltd.	598d05bc-459d-71cf-e063-6394a90a1932	2026-08-21	Warnings	Exact identifier application number: M005
Claravie	MICONAZOLE NITRATE	Gentell LLC	596d590b-e7ff-4be3-e063-6294a90a871d	2026-08-20	Warnings	Exact identifier application number: M005
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIO	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	595f9f2a-7857-0752-e063-6394a90af8de	2026-08-19	Warnings	Exact identifier application number: M005
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINE	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	595fd84a-fead-3818-e063-6394a90aa4f1	2026-08-19	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER vanilla cream	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	594bb903-2406-abb9-e063-6294a90a1cee	2026-08-18	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER rose petal	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	594befe7-1701-02a2-e063-6294a90a236c	2026-08-18	Warnings	Exact identifier application number: M005
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUT	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	594c32b7-6905-4ab9-e063-6294a90a1db3	2026-08-18	Warnings	Exact identifier application number: M005
BYT BANGYTONG FOLLICULITIS	5% BENZOYL PEROXIDE FOLLICULITIS	Shenzhen Jindali Technology Co., Ltd	595363f9-6aee-93a5-e063-6394a90a0f0e	2026-08-18	Warnings	Exact identifier application number: M005
Clotrimazole 1% Athletes Foot	CLOTRIMAZOLE	Shield Line LLC	9ddb13cd-34ed-2d63-e053-2a95a90ad9da	2026-08-18	Warnings	Exact identifier application number: M005
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLA	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	595f0c9f-645d-a047-e063-6294a90a996a	2026-08-18	Warnings	Exact identifier application number: M005
FUNGAL NAIL PATCHES	TOLNAFTATE	Yunqi Cosmetics (Shenzhen) Co., Ltd	5939c492-6481-ddae-e063-6294a90a40bb	2026-08-17	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER cherry rouge	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	593a7fc9-8d56-f9cb-e063-6294a90a3dae	2026-08-17	Warnings	Exact identifier application number: M005
APUREE Maximum Strength Athletes Foot Antifungal	APUREE MAXIMUM STRENGTH ATHLETES FOOT ANTIFUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	593dc9a3-ae04-5642-e063-6294a90adb4b	2026-08-17	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Sea Salt Green Herbs	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	59259ea7-f1bb-9688-e063-6394a90afb3c	2026-08-16	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Marshmallow Vanilla	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	5925e9a7-eb93-c0e3-e063-6294a90ad265	2026-08-16	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Lychee Vanilla Milk	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	592625c8-cbc5-f864-e063-6394a90aeb9d	2026-08-16	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Banana Cream Sugar	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	5912d7e8-94a7-e8b9-e063-6394a90a74d6	2026-08-15	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Caramel Vanilla Popcorn	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	591317be-856e-1374-e063-6394a90a7aaf	2026-08-15	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