KOITE 12% Azelaie Acid Balancing Face Cream
- Product NDC
- 84507-037
- 11-digit product format
- 845070037
- Labeler code
- 84507
- Product ID
- 84507-037_31c7b6f2-9257-8c69-e063-6394a90a749c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Face Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Guangdong Miaolian Cosmetics Co., Ltd.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-02
- Substance
- AZELAIC ACID
- Active strength
- 12 mg/100g
- Pharmacologic classes
- Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KOITE 12% Azelaie Acid Balancing Face Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELAIC ACID | 12 mg/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F2VW3D43YT |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84507-037-01 | KOITE 12% Azelaie Acid Balancing Face Cream | 30 g in 1 TUBE | CREAM | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84507-037 | KOITE 12% AZELAIE ACID BALANCING FACE CREAM (FACE CREAM) CREAM [GUANGDONG MIAOLIAN COSMETICS CO., LTD.] | 1 | Current NDC, 1 package rows | 20250406_31c7b6f2-9256-8c69-e063-6394a90a749c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84507-037-01 | 84507003701 | 30 g in 1 TUBE (84507-037-01) | 30 g | 2025-04-02 | No | No | Current |