Teeth Whitening Kit Cream
NDC Package 83778-002-01

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

Package Information

Teeth Whitening Kit cream is 1. This formulation utilizes a cream delivery system. Marketed by Jiangxi Dentalbright Technology Co., Ltd, this product is identified by NDC 83778-002.

Identification & Billing

NDC Package Code
83778-002-01
Package Description
6 mL in 1 BOTTLE
Product Code
83778-002
11-Digit Billing Format
83778000201

Clinical Specifications

Proprietary Name
Teeth Whitening Kit
Non-Proprietary Name
Teeth Whitening Kit
Substance Name
Phthalimidoperoxycaproic Acid; Potassium Citrate; Tribasic Calcium Phosphate
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)
Pharmacologic Class
Usage Information
1. Dry your teeth and rinse mouthpiece before use. 2. Looking in the mirror to record which stage you are with shade guide paper. 3. Twist whitening pen until the gel flows. apply the gel evenly on both upper and lower teeth. Each time use about 0.5-0.7ml. 4. Put mouthpiece into your mouth and bite it, then press power button for 1.5 seconds to start the treatment. (Tips: start with blue color, press again to turn red within 5 seconds; double press to turn red and blue within 5 seconds.) 5. The led light will turn off automatically after 16 minutes, rinse the mouthpiece and mouth with water and compare your teeth with shade guide paper again to see how many stages you have improved. 6. Don't eat or drink anything except water in 30 minutes after treatment.

Regulatory & Marketing

Labeler Name
Jiangxi Dentalbright Technology Co., Ltd
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-05-2023
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 83778-002-01 identifies a specific commercial package of 6 ml in 1 bottle of Teeth Whitening Kit, a human over the counter drug labeled by Jiangxi Dentalbright Technology Co., Ltd. This cream is formulated for topical use and contains phthalimidoperoxycaproic acid; potassium citrate; tribasic calcium phosphate 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 Jiangxi Dentalbright Technology Co., Ltd on November 05, 2023. The current certification is valid through December 31, 2027.

How is this Jiangxi Dentalbright Technology Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83778000201. 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)
83778-002-01
11-Digit CMS (5-4-2)
83778-0002-01

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