14% Azelaic Acid Acne

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: 14% Azelaic Acid Acne
Generic name: AZELAIC ACID
Manufacturer: Guangdong Bisutang Biotechnology Co., Ltd.
Product type: HUMAN OTC DRUG
SPL set ID: 4ccaa734-83be-611b-e063-6294a90ab3bf
SPL ID: 4ccaa734-83bf-611b-e063-6294a90ab3bf
Version: 1
Effective date: 2026-03-11
Source export date: 2026-11-06
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:47:03

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M006	openfda.application_number
brand name		14% Azelaic Acid Acne	openfda.brand_name
generic name		AZELAIC ACID	openfda.generic_name
manufacturer name		Guangdong Bisutang Biotechnology Co., Ltd.	openfda.manufacturer_name
ndc	package	84753-056-01	openfda.package_ndc
ndc	product	84753-056	openfda.product_ndc
ndc11	package	84753005601	derived:openfda.package_ndc
rxcui		2738813	openfda.rxcui
spl id		4ccaa734-83bf-611b-e063-6294a90ab3bf	id
spl set id		4ccaa734-83be-611b-e063-6294a90ab3bf	set_id
unii		F2VW3D43YT	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings:For external use only Avoid contact with eyes and mucous membranes.Mild irritation,redness.or dryness may occur.Stop use and ask a doctor if severe irritation occurs or if symptoms worsen.Do not use on broken or irritated skin or if allergic to any ingredient.lf pregnant or breast-feeding,ask a health professional before use.Keep out of reach of children.If swallowed,get medical help right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.