Sodium Fluoride Paste, Dentifrice
NDC Package 67239-0227-0

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

Package Information

Sodium Fluoride pastes is a medication used to prevent cavities. This formulation utilizes a paste, dentifrice delivery system. Marketed by Safco Dental Supply Llc, this product is identified by NDC 67239-0227 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
67239-0227-0
Package Description
72 TUBE in 1 BOX / 24 g in 1 TUBE
Product Code
67239-0227
11-Digit Billing Format
67239022700
RxNorm Crosswalk
  • RxCUI: 891775 - sodium fluoride 0.243 % Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Sodium Fluoride
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 2.43 mg/g
Usage Information
This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

Regulatory & Marketing

Labeler Name
Safco Dental Supply Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-24-2023
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 67239-0227-0 identifies a specific commercial package of 72 tube in 1 box / 24 g in 1 tube of Sodium Fluoride, a human over the counter drug labeled by Safco Dental Supply Llc. This paste, dentifrice is formulated for dental use and contains 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 Safco Dental Supply Llc on April 24, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

How is this Safco Dental Supply Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67239022700. 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 (5-4-1)
67239-0227-0
11-Digit CMS (5-4-2)
67239-0227-00

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