Home NDC 10135-671 Clotrimazole
Product NDC 10135-671
11-digit product format 101350671
Labeler code 10135
Product ID 10135-671_40a87948-bcf6-0552-e063-6394a90a2d0d
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler Marlex Pharmaceuticals Inc
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-01
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 10135-671-81 Clotrimazole 10 mL in 1 BOTTLE SOLUTION 10 8 10135-671-81 Clotrimazole 1 in 1 CARTON SOLUTION 1 8 10135-671-91 Clotrimazole 1 in 1 CARTON SOLUTION 1 8 10135-671-91 Clotrimazole 30 mL in 1 BOTTLE SOLUTION 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-671 CLOTRIMAZOLE SOLUTION [MARLEX PHARMACEUTICALS INC] 7 Current NDC, Legacy NDC, 4 package rows 20240719_d6e95c99-e055-436a-8ee6-40d6e199eaca.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 10135-671-81 10135067181 1 BOTTLE in 1 CARTON (10135-671-81) / 10 mL in 1 BOTTLE 1 bottle 2018-12-01 0000-00-00 No No Current 10135-671-91 10135067191 1 BOTTLE in 1 CARTON (10135-671-91) / 30 mL in 1 BOTTLE 1 bottle 2020-02-01 0000-00-00 No No Current