15% Azelaic Acid Cream
NDC Package 88114-001-01

11-digit billing NDC: 88114000101
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

15% Azelaic Acid Cream (azelaic acid) cream is for the management of acne. This formulation utilizes a cream delivery system. Marketed by Hongkong King Shiu Technology Limited, this product is identified by NDC 88114-001 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
88114-001-01
Package Description
30 g in 1 BOTTLE
Product Code
88114-001
11-Digit Billing Format
88114000101

Clinical Specifications

Proprietary Name
15% Azelaic Acid Cream
Non-Proprietary Name
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 15 g/100g
Pharmacologic Class
Usage Information
For the management of acne

Regulatory & Marketing

Labeler Name
Hongkong King Shiu Technology Limited
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-08-2026
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 88114-001-01 identifies a specific commercial package of 30 g in 1 bottle of 15% Azelaic Acid Cream, a human over the counter drug labeled by Hongkong King Shiu Technology Limited. 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 Hongkong King Shiu Technology Limited on October 08, 2026. The current certification is valid through December 31, 2027.

How is this Hongkong King Shiu Technology Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 88114000101. 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)
88114-001-01
11-Digit CMS (5-4-2)
88114-0001-01

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