Home NDC 54633-018 Clotrimazole
Product NDC 54633-018
11-digit product format 546330018
Labeler code 54633
Product ID 54633-018_47e33dcd-5234-6087-e063-6294a90aa9f9
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler The Podiatree Company
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-03-30
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 54633-018-10 Clotrimazole 1 in 1 CARTON SOLUTION 1 2 54633-018-10 Clotrimazole 10 mL in 1 BOTTLE SOLUTION 10 2 54633-018-30 Clotrimazole 30 mL in 1 BOTTLE SOLUTION 30 2 54633-018-30 Clotrimazole 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54633-018 CLOTRIMAZOLE SOLUTION [THE PODIATREE COMPANY] 1 Current NDC, Legacy NDC, 2 package rows 20180330_68a4e3f5-f84d-5650-e053-2a91aa0a171d.zip 54633-018 CLOTRIMAZOLE SOLUTION [THE PODIATREE COMPANY] 1 Current NDC, Legacy NDC, 2 package rows 20181027_79234400-0766-792c-e053-2a91aa0a6e6d.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 54633-018-10 54633001810 1 BOTTLE in 1 CARTON (54633-018-10) / 10 mL in 1 BOTTLE 1 bottle 2018-03-30 0000-00-00 No No Current 54633-018-30 54633001830 1 BOTTLE in 1 CARTON (54633-018-30) / 30 mL in 1 BOTTLE 1 bottle 2018-10-26 0000-00-00 No No Current