Home NDC 71457-523 Clotrimazole
Product NDC 71457-523
11-digit product format 714570523
Labeler code 71457
Product ID 71457-523_5a5cfee7-0051-57fe-e063-6394a90a113c
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler InvaDerm Corporation
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-09-01
Substance CLOTRIMAZOLE
Active strength 1 g/mL
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 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.
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 36 of 49 · 969 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71457-523-10 71457052310 10 mL in 1 BOTTLE (71457-523-10) 10 ml 2026-09-01 No No Current 71457-523-30 71457052330 30 mL in 1 BOTTLE (71457-523-30) 30 ml 2026-09-01 No No Current