Home NDC 11523-0133 Lotrimin
Product NDC 11523-0133
11-digit product format 115230133
Labeler code 11523
Product ID 11523-0133_4526d12f-4d38-c729-e063-6294a90a50d6
Type HUMAN OTC DRUG
Nonproprietary name Miconazole nitrate
Dosage form AEROSOL, POWDER
Route TOPICAL
Labeler Bayer Healthcare LLC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-29
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
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 Lotrimin
Brand name suffix AF Jock Itch
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 20 mg/g
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 998428 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 11523-0133-1 LotriminAF Jock Itch 133 g in 1 CAN AEROSOL, POWDER 133 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-0133 LOTRIMIN AF JOCK ITCH (MICONAZOLE NITRATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.] 1 Current NDC, 1 package rows 20240123_0c53cf0f-767e-a422-e063-6394a90ab764.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 11523-0133-1 11523013301 133 g in 1 CAN (11523-0133-1) 133 g 2023-11-29 No No Current