Home NDC 0363-5353 Miconazole Nitrate 2%
Product NDC 0363-5353
11-digit product format 003635353
Labeler code 0363
Product ID 0363-5353_534c6399-4176-95bb-e063-6394a90abb76
Type HUMAN OTC DRUG
Nonproprietary name Jock Itch Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Walgreens Company
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-28
Substance MICONAZOLE NITRATE
Active strength 1.3 g/131g
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%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 1.3 g/131g
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 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 0363-5353-00 Miconazole Nitrate 2% 131 g in 1 CAN AEROSOL, SPRAY 131 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-5353 MICONAZOLE NITRATE 2% (JOCK ITCH SPRAY) AEROSOL, SPRAY [WALGREENS COMPANY] 4 Current NDC, Legacy NDC, 1 package rows 20241211_cf6cbaf4-beba-6fdf-e053-2995a90a76d2.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 39 of 49 · 969 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-5353-00 00363535300 131 g in 1 CAN (0363-5353-00) 131 g 2021-10-28 0000-00-00 No No Current