Home NDC 84753-056 14% Azelaic Acid Acne
Product NDC 84753-056
11-digit product format 847530056
Labeler code 84753
Product ID 84753-056_4ccaa734-83bf-611b-e063-6294a90ab3bf
Type HUMAN OTC DRUG
Nonproprietary name Azelaic Acid
Dosage form CREAM
Route TOPICAL
Labeler Guangdong Bisutang Biotechnology Co., Ltd.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-12
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 Acne
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2738813 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 84753-056-01 14% Azelaic Acid Acne 30 g 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 44 of 55 · 1,088 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 84753-056-01 84753005601 30 g in 1 BOTTLE (84753-056-01) 30 g 2026-03-12 No No Current