Home NDC 85248-138 Beilloso Balanitis Relief
Product NDC 85248-138
11-digit product format 852480138
Labeler code 85248
Product ID 85248-138_54428bfa-6c84-0067-e063-6394a90a11c4
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate 2% Balanitis Relief
Dosage form CREAM
Route TOPICAL
Labeler Jiangxi Yudexi Pharmaceutical Co., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-10
Substance MICONAZOLE NITRATE
Active strength 2 g/100mL
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 Beilloso Balanitis Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/100mL
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 85248-138-01 Beilloso Balanitis Relief 30 mL in 1 BOTTLE CREAM 30 1
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 Sample Exclude flag Status 85248-138-01 85248013801 30 mL in 1 BOTTLE (85248-138-01) 30 ml 2026-02-10 No No Current