Home NDC 87879-001 Clotrimazole
Product NDC 87879-001
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.
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.
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