Home NDC 69396-143 Clotrimazole Antifungal
Product NDC 69396-143
11-digit product format 693960143
Labeler code 69396
Product ID 69396-143_11bf503d-be71-0b75-e063-6394a90aa94e
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA, LLC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-13
Substance CLOTRIMAZOLE
Active strength 10 g/L
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 Antifungal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 g/L
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 309370 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 69396-143-33 Clotrimazole Antifungal 1 in 1 BOX SOLUTION 1 1 69396-143-33 Clotrimazole Antifungal 0.01 L in 1 BOTTLE SOLUTION 0.01 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-143 CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [TRIFECTA PHARMACEUTICALS USA, LLC.] 1 Current NDC, 2 package rows 20240223_11bf50db-552e-0a39-e063-6394a90af60d.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 Sample Exclude flag Status 69396-143-33 69396014333 1 BOTTLE in 1 BOX (69396-143-33) / .01 L in 1 BOTTLE 1 bottle 2023-11-13 No No Current