Bloomellee 14%gel Azelaic Acid Cream
NDC Package 87386-002-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bloomellee 14%gel Azelaic Acid Cream (14%azelaic acid) cream is a medication used to treat a certain skin condition called rosacea. This formulation utilizes a cream delivery system. Marketed by Shenzhen Lanxi Trading Co., Ltd., this product is identified by NDC 87386-002 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
87386-002-01
Package Description
1 BOTTLE, DROPPER in 1 BOX / 40 g in 1 BOTTLE, DROPPER
Product Code
87386-002
11-Digit Billing Format
87386000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bloomellee 14%gel Azelaic Acid Cream
Non-Proprietary Name
14%azelaic Acid
Substance Name
Azelaic Acid
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
AZELAIC ACID .14 g/g
Pharmacologic Class
Usage Information
This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.

Regulatory & Marketing

Labeler Name
Shenzhen Lanxi Trading Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-25-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 87386-002-01 identifies a specific commercial package of 1 bottle, dropper in 1 box / 40 g in 1 bottle, dropper of Bloomellee 14%gel Azelaic Acid Cream, a human over the counter drug labeled by Shenzhen Lanxi Trading Co., Ltd.. This cream is formulated for topical use and contains azelaic acid as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Shenzhen Lanxi Trading Co., Ltd. on May 25, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.

How is this Shenzhen Lanxi Trading Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87386000201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
87386-002-01
11-Digit CMS (5-4-2)
87386-0002-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.