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 |
|---|
| ASIATICOSIDE | .015 g/100g |
| AZELAIC ACID | 15 g/100g |
| CAPRYLOYL GLYCINE | .15 g/100g |
| CENTELLA ASIATICA TRITERPENOIDS | .03 g/100g |
| HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID | .5 g/100g |
| LAVANDIN OIL | .03 g/100g |
| MADECASSOSIDE | .055 g/100g |
| O-CYMEN-5-OL | .09 g/100g |
| TARAXACUM OFFICINALE LEAF | .01 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PKO39VY215, F2VW3D43YT, 8TY5YO42NJ, 4YS74Q4G4J, RWW266YE9I, 9RES347CKG, CQ2F5O6YIY, H41B6Q1I9L, 0022LFJ74Y |
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 |
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 | Historical |