Clotrimazole

Product NDC: 87879-001
Requested package NDC: 87879-001-01
11-digit product format: 878790001
Labeler code: 87879
Product ID: 87879-001_572a5f74-6424-66c8-e063-6394a90ae812
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: GRANULE
Route: TOPICAL
Labeler: Shaanxi Shuvita Biotech Co., Ltd
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-07-22
Substance: CLOTRIMAZOLE
Active strength: 100 kg/100kg
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	100 kg/100kg

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
572a5f3d-fb46-5dfa-e063-6294a90a722b	Available on FDA.report

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Shaanxi Shuvita Biotech Co., Ltd	572a5f3d-fb46-5dfa-e063-6294a90a722b	2026-07-21	Warnings	Exact identifier ndc (package): 87879-001-01 ndc (product): 87879-001 ndc11 (package): 87879000101

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	Sample	Exclude flag	Status
87879-001-01	87879000101	25 kg in 1 PAIL (87879-001-01)	25 kg	2026-07-22	No	No	Current