Clotrimazole (Topical Solution), 1%

Product NDC: 83474-003
11-digit product format: 834740003
Labeler code: 83474
Product ID: 83474-003_46f2ddcb-401f-9ed7-e063-6394a90a7a63
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Puro Pharma Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-04-15
Substance: CLOTRIMAZOLE
Active strength: 10 mg/mL
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 (Topical Solution), 1%
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309370	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
cb424fa8-3ed5-45cd-b03f-64675584b34e	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83474-003-34	Clotrimazole (Topical Solution), 1%	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		2
83474-003-34	Clotrimazole (Topical Solution), 1%	1 in 1 CARTON	SOLUTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83474-003-34	ML - Milliliter	83474-003	fbc946b3-cb33-454d-8110-796ab938c1c9	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83474-003	CLOTRIMAZOLE (TOPICAL SOLUTION), 1% (CLOTRIMAZOLE) SOLUTION [PURO PHARMA INC.]	1	Current NDC, 2 package rows	20240415_cb424fa8-3ed5-45cd-b03f-64675584b34e.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 25 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Antifungal Maximum Strength	UNDECYLENIC ACID	TOPCO ASSOCIATES LLC	7c44fb4e-0eef-4ced-b03f-a02ebe6c0264	2025-12-22	Warnings	Exact identifier application number: M005
Fungi Nail Toe and Foot	TOLNAFTATE	Kramer Laboratories	a3ae043b-dc97-449b-b099-70bdf8e92482	2025-12-19	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	RUGBY LABORATORIES	6de9155b-7070-38fd-e053-2a91aa0af6f6	2025-12-19	Warnings	Exact identifier application number: M005
HC Max Anti-Fungal	TOLNAFTATE	Kramer Laboratories	ee99cd87-549f-4a43-878e-b4d5935de0e0	2025-12-19	Warnings	Exact identifier application number: M005
Fungi Nail Anti-Fungal Pen	TOLNAFTATE	Kramer Laboratories	1a0a3b14-d8f2-4363-b3c9-f5028e8eada3	2025-12-19	Warnings	Exact identifier application number: M005
Tolnaftate	FOOT ODOR CONTROL POWDER SPRAY	Winco Foods, LLC	cc257a18-247f-c787-e053-2a95a90a075a	2025-12-16	Warnings	Exact identifier application number: M005
Tolnaftate	ODOR CONTROL POWDER SPRAY	Walgreen Company	a113f568-bd20-4f02-8e09-1b8223a0a9fa	2025-12-16	Warnings	Exact identifier application number: M005
Tobcharm Toenail Fungus Treatment Liquid	TOENAIL FUNGUS TREATMENT LIQUID	Guangzhou Qiexiran Cosmetics Co., Ltd.	45f92be2-0677-5989-e063-6394a90af280	2025-12-15	Warnings	Exact identifier application number: M005
TEA TREE Oil ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	45bd3ad0-a0d1-314f-e063-6394a90a9a3a	2025-12-12	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Topco Associates LLC	97334166-1dff-4ed2-ad31-f524b22097f9	2025-12-12	Warnings	Exact identifier application number: M005
Foot Odor Control Powder	TOLNAFTATE	Meijer Distribution Inc	03fd2680-0040-aa8c-e063-6294a90a090f	2025-12-12	Warnings	Exact identifier application number: M005
Foot Odor Control Powder	TOLNAFTATE	Premier Brands of America Inc.	edb0a2da-aaa1-3b9b-e053-2995a90a5012	2025-12-12	Warnings	Exact identifier application number: M005
Pedikleer	TOLNAFTATE	Rising Pharma Holdings, Inc.	83396c51-7107-4d98-9d80-ebf6584f4dc8	2025-12-11	Warnings	Exact identifier application number: M005
ELAIMEI FUNGAL NAIL PATCHES	TEA TREE OIL	Shenzhen Shandian Jingling Technology Co., Ltd.	457d08eb-e812-8f12-e063-6294a90ab85f	2025-12-10	Warnings	Exact identifier application number: M005
Lofuanna FUNGAL NAIL PATCHES	TEA TREE OIL	Shenzhen Shandian Jingling Technology Co., Ltd.	43da9ec2-5f2f-dfce-e063-6394a90aecca	2025-12-10	Warnings	Exact identifier application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%	UNDECYLENIC ACID 25%	Shenzhen Shandian Jingling Technology Co., Ltd.	457f819b-0850-a97c-e063-6394a90ac368	2025-12-09	Warnings	Exact identifier application number: M005
NAIL REPAIR PEN	UNDECYLENIC ACID	Yunqi Cosmetics (Shenzhen) Co., Ltd	45814b84-0e51-6c9d-e063-6394a90a2905	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAY	Better Living Brands	ccfef81b-f271-4551-e053-2a95a90a8ac4	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREE	Foodhold USA	a64c9371-0ac7-4c47-bc12-7bc77162b244	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Harris Teeter, LLC	02eb9c78-5a89-4958-b5a4-68f39e584cf2	2025-12-09	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
309370	clotrimazole 1 % Topical Solution	PSN	cb424fa8-3ed5-45cd-b03f-64675584b34e	2
309370	clotrimazole 10 MG/ML Topical Solution	SCD	cb424fa8-3ed5-45cd-b03f-64675584b34e	2
309370	clotrimazole 1 % Topical Solution	SY	cb424fa8-3ed5-45cd-b03f-64675584b34e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83474-003-34	83474000334	1 BOTTLE, DROPPER in 1 CARTON (83474-003-34) / 10 mL in 1 BOTTLE, DROPPER	2024-04-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole (Topical Solution) USP, 1%	Puro Pharma Inc. \| InvaDerm Corporation	2025-12-27	HUMAN OTC DRUG LABEL	2