Glorysmile Toothpaste. Paste, Dentifrice
NDC Package 83778-010-01

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

Package Information

Glorysmile Toothpaste. pastes is 1. This formulation utilizes a paste, dentifrice delivery system. Marketed by Jiangxi Dentalbright Technology Co., Ltd, this product is identified by NDC 83778-010 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
83778-010-01
Package Description
60 g in 1 BOTTLE
Product Code
83778-010
11-Digit Billing Format
83778001001

Clinical Specifications

Proprietary Name
Glorysmile Toothpaste.
Non-Proprietary Name
Glorysmile Toothpaste.
Substance Name
Sodium Fluoride; Sodium Gluconate
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
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)
Usage Information
1. Apply 2 pumps to a soft bristle toothbrush. 2. Gently brush it a circular motion for 2 minutes. 3. Expel excess and rinse mouth after use, do not swallow.

Regulatory & Marketing

Labeler Name
Jiangxi Dentalbright Technology Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-24-2023
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 83778-010-01 identifies a specific commercial package of 60 g in 1 bottle of Glorysmile Toothpaste., a human over the counter drug labeled by Jiangxi Dentalbright Technology Co., Ltd. This paste, dentifrice is formulated for topical use and contains sodium fluoride; sodium gluconate 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 October 24, 2023. The current certification is valid through December 31, 2026.

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: 83778001001. 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)
83778-010-01
11-Digit CMS (5-4-2)
83778-0010-01

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