Home NDC 68788-4080 Clotrimazole
Product NDC 68788-4080
11-digit product format 687884080
Labeler code 68788
Product ID 68788-4080_d6f5c6b5-5e56-462f-8c47-7986ce53669d
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-25
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-4080-1 Clotrimazole 10 mL in 1 BOTTLE SOLUTION 10 1
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 8 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-4080-1 68788408001 10 mL in 1 BOTTLE (68788-4080-1) 10 ml 2026-02-25 No No Current