Bloomellee 12%Gel Azelaic Acid Acne
- Product NDC
- 87386-003
- 11-digit product format
- 873860003
- Labeler code
- 87386
- Product ID
- 87386-003_52a1905e-c89c-9dd1-e063-6294a90af10c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- 12%Azelaic Acid
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Shenzhen Lanxi Trading Co., Ltd.
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-25
- Substance
- AZELAIC ACID
- Active strength
- .12 g/g
- 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
- Bloomellee 12%Gel Azelaic Acid Acne
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELAIC ACID | .12 g/g |
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 |
|---|
| 87386-003-01 | Bloomellee 12%Gel Azelaic Acid Acne | 1 in 1 BOX | CREAM | 1 | | 3 |
| 87386-003-01 | Bloomellee 12%Gel Azelaic Acid Acne | 30 g in 1 BOTTLE, DROPPER | CREAM | 30 | | 3 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 87386-003-01 | 87386000301 | 1 BOTTLE, DROPPER in 1 BOX (87386-003-01) / 30 g in 1 BOTTLE, DROPPER | 2026-05-25 | No | No | Historical |