koite 12% azelaie acid balancing face cream

Generic: face cream

Labeler: guangdong miaolian cosmetics co., ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name koite 12% azelaie acid balancing face cream
Generic Name face cream
Labeler guangdong miaolian cosmetics co., ltd.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

azelaic acid 12 mg/100g

Manufacturer
Guangdong Miaolian Cosmetics Co., Ltd.

Identifiers & Regulatory

Product NDC 84507-037
Product ID 84507-037_31c7b6f2-9257-8c69-e063-6394a90a749c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2025-04-02

Pharmacologic Class

Physiologic Effect
decreased protein synthesis [pe] decreased sebaceous gland activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84507037
Hyphenated Format 84507-037

Supplemental Identifiers

UNII
F2VW3D43YT
NUI
N0000008841 N0000009982

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name koite 12% azelaie acid balancing face cream (source: ndc)
Generic Name face cream (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/100g
source: ndc
Packaging
  • 30 g in 1 TUBE (84507-037-01)
source: ndc

Packages (1)

84507-037-01 30 g in 1 TUBE (84507-037-01)

Ingredients (1)

azelaic acid (12 mg/100g)

Linked Drug Pages (1)

KOITE 12% Azelaie Acid Balancing Face Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "31c7b6f2-9257-8c69-e063-6394a90a749c", "openfda": {"nui": ["N0000008841", "N0000009982"], "unii": ["F2VW3D43YT"], "spl_set_id": ["31c7b6f2-9256-8c69-e063-6394a90a749c"], "pharm_class_pe": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "manufacturer_name": ["Guangdong Miaolian Cosmetics Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 TUBE (84507-037-01)", "package_ndc": "84507-037-01", "marketing_start_date": "20250402"}], "brand_name": "KOITE 12% Azelaie Acid Balancing Face Cream", "product_id": "84507-037_31c7b6f2-9257-8c69-e063-6394a90a749c", "dosage_form": "CREAM", "pharm_class": ["Decreased Protein Synthesis [PE]", "Decreased Sebaceous Gland Activity [PE]"], "product_ndc": "84507-037", "generic_name": "Face Cream", "labeler_name": "Guangdong Miaolian Cosmetics Co., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "KOITE 12% Azelaie Acid Balancing Face Cream", "active_ingredients": [{"name": "AZELAIC ACID", "strength": "12 mg/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250402", "listing_expiration_date": "20261231"}