Home NDC 69396-087 Clotrimazole
Product NDC 69396-087
11-digit product format 693960087
Labeler code 69396
Product ID 69396-087_4bf9a459-7b08-9a01-e063-6294a90ac7b9
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler TRIFECTA PHARMACEUTICALS USA LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-08
Substance CLOTRIMAZOLE
Active strength 1 g/100g
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/100g
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 69396-087-01 Clotrimazole 28.4 g in 1 TUBE CREAM 28.4 5 69396-087-01 Clotrimazole 1 in 1 BOX CREAM 1 5 69396-087-55 Clotrimazole 5 in 1 BOX CREAM 5 5 69396-087-55 Clotrimazole 28.4 g in 1 TUBE CREAM 28.4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-087 CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC] 4 Current NDC, Legacy NDC, 4 package rows 20240330_e0a2a907-9c3a-4c4e-e053-2995a90abb91.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 36 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 69396-087-01 69396008701 1 TUBE in 1 BOX (69396-087-01) / 28.4 g in 1 TUBE 1 tube 2022-06-04 0000-00-00 No No Current 69396-087-55 69396008755 5 TUBE in 1 BOX (69396-087-55) / 28.4 g in 1 TUBE 5 tube 2022-04-08 No No Current