Darkspotremoverilluminatingfacecream Emulsion
NDC Package 84423-046-01

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

Package Information

Darkspotremoverilluminatingfacecream emulsions is thie s mdieturizina croam onrichod fem avouieito and powertul ingredients that also removes dark spots (from acne. This formulation utilizes a emulsion delivery system. Marketed by Guangzhou Kadiya Biotechnology Co., Ltd., this product is identified by NDC 84423-046 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
84423-046-01
Package Description
30 mL in 1 BOTTLE, GLASS
Product Code
84423-046
11-Digit Billing Format
84423004601

Clinical Specifications

Proprietary Name
Darkspotremoverilluminatingfacecream
Non-Proprietary Name
Darkspotremoverilluminatingfacecream
Substance Name
Alpha-arbutin; Ascorbic Acid; Tocopherol
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Thie s mdieturizina croam onrichod fem avouieito and powertul ingredients that also removes dark spots (from acne. hvper pigmentation, etc). It contains vitamins C & E and provides a SPF of 15. This product will nourish and refine skin. linhten dark snots and smooth nores This product has been formulated for sensitive skin.

Regulatory & Marketing

Labeler Name
Guangzhou Kadiya Biotechnology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-17-2024
Listing Expiration
12-31-2026
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 84423-046-01 identifies a specific commercial package of 30 ml in 1 bottle, glass of Darkspotremoverilluminatingfacecream, a human over the counter drug labeled by Guangzhou Kadiya Biotechnology Co., Ltd.. This emulsion is formulated for cutaneous use and contains alpha-arbutin; ascorbic acid; tocopherol 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 Guangzhou Kadiya Biotechnology Co., Ltd. on December 17, 2024. The current certification is valid through December 31, 2026.

How is this Guangzhou Kadiya Biotechnology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84423004601. 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)
84423-046-01
11-Digit CMS (5-4-2)
84423-0046-01

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