Home NDC 69848-001 Clotrimazole
Product NDC 69848-001
11-digit product format 698480001
Labeler code 69848
Product ID 69848-001_4690b8d8-7cc2-ebf2-e063-6294a90af113
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler Granules USA, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-01
Substance CLOTRIMAZOLE
Active strength 1 g/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
Listing expiration 2026-12-31 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 69848-001-01 Clotrimazole 10 mL in 1 BOTTLE SOLUTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69848-001 CLOTRIMAZOLE SOLUTION [GRANULES USA, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240103_6e63e29a-eb50-1790-e053-2a91aa0a3616.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 8 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69848-001-01 69848000101 10 mL in 1 BOTTLE (69848-001-01) 10 ml 2018-07-01 0000-00-00 No No Current