Home NDC 69396-014 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Product NDC 69396-014
11-digit product format 693960014
Labeler code 69396
Product ID 69396-014_4e55e0bf-9e9d-d877-e063-6294a90a9d59
Type HUMAN OTC DRUG
Nonproprietary name MICONAZOLE NITRATE
Dosage form CREAM
Route TOPICAL
Labeler Trifecta Pharmaceuticals Usa Llc
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-03-22
Substance MICONAZOLE NITRATE
Active strength 2 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 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998483 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 69396-014-04 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 118.3 g in 1 TUBE CREAM 118.3 14 69396-014-05 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 15 g in 1 TUBE CREAM 15 14 69396-014-20 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 1 in 1 BOX CREAM 1 14 69396-014-20 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 30 g in 1 TUBE CREAM 30 14 69396-014-33 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 3 in 1 BOX CREAM 3 14 69396-014-33 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 30 g in 1 TUBE CREAM 30 14 69396-014-44 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 30 g in 1 TUBE CREAM 30 14 69396-014-44 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 4 in 1 BOX CREAM 4 14 69396-014-66 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 6 in 1 BOX CREAM 6 14 69396-014-66 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 30 g in 1 TUBE CREAM 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-014 MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC] 13 Current NDC, Legacy NDC, 10 package rows 20250207_80217dbb-a0f0-414a-8d22-a9a346b017aa.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 51 · 1,004 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 69396-014-04 69396001404 118.3 g in 1 TUBE (69396-014-04) 118.3 g 2022-09-23 No No Current 69396-014-05 69396001405 15 g in 1 TUBE (69396-014-05) 15 g 2016-03-22 0000-00-00 No No Current 69396-014-20 69396001420 1 TUBE in 1 BOX (69396-014-20) / 30 g in 1 TUBE 1 tube 2016-03-22 0000-00-00 No No Current 69396-014-33 69396001433 3 TUBE in 1 BOX (69396-014-33) / 30 g in 1 TUBE 3 tube 2024-03-22 No No Current 69396-014-44 69396001444 4 TUBE in 1 BOX (69396-014-44) / 30 g in 1 TUBE 4 tube 2024-02-29 No No Current 69396-014-66 69396001466 6 TUBE in 1 BOX (69396-014-66) / 30 g in 1 TUBE 6 tube 2024-02-22 No No Current