Home NDC 84056-003 4oz
Product NDC 84056-003
11-digit product format 840560003
Labeler code 84056
Product ID 84056-003_4fc3de06-5fc3-abad-e063-6394a90ac8e0
Type HUMAN OTC DRUG
Nonproprietary name miconazole
Dosage form SOAP
Route TOPICAL
Labeler Nabrace LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-01
Substance MICONAZOLE
Active strength 1.2 g/120g
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 4oz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE 1.2 g/120g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7NNO0D7S5M 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 84056-003-04 4oz 120 g in 1 BOX SOAP 120 2
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 Sample Exclude flag Status 84056-003-04 84056000304 120 g in 1 BOX (84056-003-04) 120 g 2022-08-01 No No Current