FDA.reportPublic FDA data

10% azelaic acid acne cream

Product NDC
84148-009
11-digit product format
841480009
Labeler code
84148
Product ID
84148-009_4c6723a7-8506-44e0-e063-6294a90af299
Type
HUMAN OTC DRUG
Nonproprietary name
10% azelaic acid acne cream
Dosage form
CREAM
Route
CUTANEOUS
Labeler
Guangzhou Ariel Biotech Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-29
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; 10; .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
10% azelaic acid acne cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELAIC ACID.015 g/100g
MADECASSOSIDE10 g/100g
CENTELLA ASIATICA TRITERPENOIDS.15 g/100g
LAVANDIN OIL.03 g/100g
ASIATICOSIDE.5 g/100g
O-CYMEN-5-OL.03 g/100g
CAPRYLOYL GLYCINE.055 g/100g
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID.09 g/100g
TARAXACUM OFFICINALE LEAF.01 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2VW3D43YTInternal UNII lookup
CQ2F5O6YIYInternal UNII lookup
4YS74Q4G4JInternal UNII lookup
9RES347CKGInternal UNII lookup
PKO39VY215Internal UNII lookup
H41B6Q1I9LInternal UNII lookup
8TY5YO42NJInternal UNII lookup
RWW266YE9IInternal UNII lookup
0022LFJ74YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
233ed88c-7e76-f8ad-e063-6394a90aa53eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84148-009-012026-01-29C16284748780-149896155-b05f-586f-e063-e6dba90add9084148-009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84148-009-0110% azelaic acid acne cream30 g in 1 BOTTLECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84148-00910% AZELAIC ACID ACNE CREAM CREAM [GUANGZHOU ARIEL BIOTECH CO., LTD.]1Current NDC, 1 package rows20241010_233ed88c-7e76-f8ad-e063-6394a90aa53e.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10% azelaic acid acne cream10% AZELAIC ACID ACNE CREAMGuangzhou Ariel Biotech Co., Ltd.233ed88c-7e76-f8ad-e063-6394a90aa53e2026-03-06WarningsExact identifier
ndc (product): 84148-009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84148-009-018414800090130 g in 1 BOTTLE (84148-009-01) 30 g2024-09-29NoNoCurrent