Home NDC 84148-010 15% azelaic acid acne cream
Product NDC 84148-010
11-digit product format 841480010
Labeler code 84148
Product ID 84148-010_4c67351e-1260-cbf2-e063-6394a90ac443
Type HUMAN OTC DRUG
Nonproprietary name 15% azelaic acid acne cream
Dosage form CREAM
Route CUTANEOUS
Labeler Guangzhou Ariel Biotech Co., Ltd.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-09-23
Substance ASIATICOSIDE; AZELAIC ACID; CAPRYLOYL GLYCINE; CENTELLA ASIATICA TRITERPENOIDS; HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID; LAVANDIN OIL; MADECASSOSIDE; O-CYMEN-5-OL; TARAXACUM OFFICINALE LEAF
Active strength .015; 15; .15; .03; .5; .03; .055; .09; .01 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; 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 Additional Listing Data#
Finished product Yes
Brand name base 15% azelaic acid acne cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAVANDIN OIL .015 g/100g TARAXACUM OFFICINALE LEAF 15 g/100g MADECASSOSIDE .15 g/100g CENTELLA ASIATICA TRITERPENOIDS .03 g/100g ASIATICOSIDE .5 g/100g AZELAIC ACID .03 g/100g O-CYMEN-5-OL .055 g/100g CAPRYLOYL GLYCINE .09 g/100g HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID .01 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
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 84148-010-01 15% azelaic acid acne cream 30 g in 1 BOTTLE CREAM 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84148-010 15% AZELAIC ACID ACNE CREAM CREAM [GUANGZHOU ARIEL BIOTECH CO., LTD.] 1 Current NDC, 1 package rows 20241010_234ce15d-99e5-c687-e063-6394a90a8357.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84148-010-01 84148001001 30 g in 1 BOTTLE (84148-010-01) 30 g 2024-09-30 No No Current