Teeth Desensitizing And Remineralizing Gel
NDC Package 49410-200-07

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Teeth Desensitizing And Remineralizing Gel is adults and children 18 years of age and older: Directly apply 1ml-1.5ml of the product on sensitive teeth, or use it in a custom mouth tray. Marketed by Fuzhou Difeng Bio-tech Co., Ltd., this product is identified by NDC 49410-200 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
49410-200-07
Package Description
6 CONTAINER in 1 CARTON / 333 VIAL, SINGLE-USE in 1 CONTAINER / 3 g in 1 VIAL, SINGLE-USE
Product Code
49410-200
11-Digit Billing Format
49410020007
RxNorm Crosswalk
  • RxCUI: 1038841 - potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste
  • RxCUI: 1038841 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG Toothpaste
  • RxCUI: 1038841 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste
  • RxCUI: 1038841 - pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel Toothpaste
  • RxCUI: 1038841 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste

Clinical Specifications

Proprietary Name
Teeth Desensitizing And Remineralizing Gel
Dosage Form
-
Usage Information
Adults and children 18 years of age and older: Directly apply 1ml-1.5ml of the product on sensitive teeth, or use it in a custom mouth tray. Keep your mouth open for 10-15 mins. Then rinse your month to clean the gel. Use it 1-2 times daily or as recommended by a dentist or physician. Children under 18 years of age and pregnant, breast feeding women: consult a dentist or physician prior to use.

Regulatory & Marketing

Labeler Name
Fuzhou Difeng Bio-tech Co., Ltd.
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
03-07-2016
Listing Expiration
12-31-2019
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49410-200). Click a package code to view its specific billing and regulatory data.

49410-200-01
5 CONTAINER in 1 CARTON / 200 VIAL, SINGLE-USE in 1 CONTAINER / 1.5 g in 1 VIAL, SINGLE-USE
49410-200-02
5 CONTAINER in 1 CARTON / 100 VIAL, SINGLE-USE in 1 CONTAINER / 2 g in 1 VIAL, SINGLE-USE
49410-200-03
5 CONTAINER in 1 CARTON / 100 VIAL, SINGLE-USE in 1 CONTAINER / 4 g in 1 VIAL, SINGLE-USE
49410-200-04
5 CONTAINER in 1 CARTON / 80 VIAL, SINGLE-USE in 1 CONTAINER / 6 g in 1 VIAL, SINGLE-USE
49410-200-05
6 CONTAINER in 1 CARTON / 300 VIAL, SINGLE-USE in 1 CONTAINER / 4.5 g in 1 VIAL, SINGLE-USE
49410-200-06
6 CONTAINER in 1 CARTON / 200 VIAL, SINGLE-USE in 1 CONTAINER / 10 g in 1 VIAL, SINGLE-USE
49410-200-08
300 VIAL, SINGLE-USE in 1 CARTON / 3.5 g in 1 VIAL, SINGLE-USE

* 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 49410-200-07 identifies a specific commercial package of 6 container in 1 carton / 333 vial, single-use in 1 container / 3 g in 1 vial, single-use of Teeth Desensitizing And Remineralizing Gel, labeled by Fuzhou Difeng Bio-tech Co., Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Fuzhou Difeng Bio-tech Co., Ltd. on March 07, 2016. The current certification is valid through December 31, 2019.

How is this Fuzhou Difeng Bio-tech Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49410020007. 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)
49410-200-07
11-Digit CMS (5-4-2)
49410-0200-07

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