Home NDC 87386-003 Bloomellee 12%Gel Azelaic Acid Acne
Product NDC 87386-003
11-digit product format 873860003
Labeler code 87386
Product ID 87386-003_52a1905e-c89c-9dd1-e063-6294a90af10c
Type HUMAN OTC DRUG
Nonproprietary name 12%Azelaic Acid
Dosage form CREAM
Route TOPICAL
Labeler Shenzhen Lanxi Trading Co., Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-25
Substance AZELAIC ACID
Active strength .12 g/g
Pharmacologic classes Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Bloomellee 12%Gel Azelaic Acid Acne
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELAIC ACID .12 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F2VW3D43YT 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 87386-003-01 Bloomellee 12%Gel Azelaic Acid Acne 1 in 1 BOX CREAM 1 3 87386-003-01 Bloomellee 12%Gel Azelaic Acid Acne 30 g in 1 BOTTLE, DROPPER CREAM 30 3
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 87386-003-01 87386000301 1 BOTTLE, DROPPER in 1 BOX (87386-003-01) / 30 g in 1 BOTTLE, DROPPER 2026-05-25 No No Current