Home NDC 87815-003 14% Azelaic Acid
Product NDC 87815-003
11-digit product format 878150003
Labeler code 87815
Product ID 87815-003_55b03daa-b6d5-9edf-e063-6394a90ac4d1
Type HUMAN OTC DRUG
Nonproprietary name Azelaic Acid
Dosage form CREAM
Route TOPICAL
Labeler Guangzhou Ariel Medical Technology Co., Ltd.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-03
Substance AZELAIC ACID
Active strength 14 g/100g
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 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 14% Azelaic Acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELAIC ACID 14 g/100g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2738813 Internal RxNorm lookup 2746493 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 7 of 55 · 1,088 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87815-003-01 87815000301 30 g in 1 TUBE (87815-003-01) 30 g 2026-07-03 No No Current