Home NDC 54633-314 Fortinia
Product NDC 54633-314
11-digit product format 546330314
Labeler code 54633
Product ID 54633-314_47e362c2-c358-adbe-e063-6294a90a6043
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler The Podiatree Company
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-02-02
Substance CLOTRIMAZOLE
Active strength 10 mg/g
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 Fortinia
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309367 Internal RxNorm 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 54633-314-80 Fortinia 80 g in 1 BOTTLE, PUMP CREAM 80 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54633-314 FORTINIA (CLOTRIMAZOLE) CREAM [THE PODIATREE COMPANY] 3 Current NDC, Legacy NDC, 1 package rows 20171220_60ba6f8a-8617-d4f6-e053-2991aa0a4a71.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54633-314-80 54633031480 80 g in 1 BOTTLE, PUMP (54633-314-80) 80 g 2015-02-02 0000-00-00 No No Current