Sodium Fluoride And Potassium Nitrate Gel
NDC Package 69367-318-01

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

Package Information

Sodium Fluoride And Potassium Nitrate gel is a dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. This formulation utilizes a gel delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-318.

Identification & Billing

NDC Package Code
69367-318-01
Package Description
1 TUBE in 1 CARTON / 100 mL in 1 TUBE
Product Code
69367-318
11-Digit Billing Format
69367031801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 637365 - potassium nitrate 5 % / sodium fluoride 1.1 % Toothpaste
  • RxCUI: 637365 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste
  • RxCUI: 637365 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste
  • RxCUI: 637365 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste
  • RxCUI: 637365 - potassium nitrate 5 % / sodium fluoride 1.1 % Gel Toothpaste

Clinical Specifications

Proprietary Name
Sodium Fluoride And Potassium Nitrate
Non-Proprietary Name
Sodium Fluoride And Potassium Nitrate
Substance Name
Potassium Nitrate; Sodium Fluoride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
Usage Information
A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Sodium Fluoride 5000 ppm Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Regulatory & Marketing

Labeler Name
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription 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
06-15-2022
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 69367-318-01 identifies a specific commercial package of 1 tube in 1 carton / 100 ml in 1 tube of Sodium Fluoride And Potassium Nitrate, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This gel is formulated for dental use and contains potassium nitrate; sodium fluoride 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 Westminster Pharmaceuticals, Llc on June 15, 2022. The current certification is valid through December 31, 2026.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367031801. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
69367-318-01
11-Digit CMS (5-4-2)
69367-0318-01

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