Therabreath Paste, Dentifrice
NDC Package 10237-271-07

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

Therabreath (stannous fluoride) pastes is • do not swallow • supervise children as necessary until capable of using without supervisionadults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctorchildren under 6 years of ageinstruct in good brushing and rinsing habits (to minimize swallowing)children under 2 years of ageconsult a dentist or doctor. This formulation utilizes a paste, dentifrice delivery system. Marketed by Church & Dwight Co., Inc., this product is identified by NDC 10237-271 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
10237-271-07
Package Description
1 TUBE in 1 CARTON / 19 g in 1 TUBE
Product Code
10237-271
11-Digit Billing Format
10237027107
RxNorm Crosswalk
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.00454 MG/MG Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Therabreath Healthy Gums
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous 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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
STANNOUS FLUORIDE .454 g/100g
Usage Information
• do not swallow • supervise children as necessary until capable of using without supervisionadults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctorchildren under 6 years of ageinstruct in good brushing and rinsing habits (to minimize swallowing)children under 2 years of ageconsult a dentist or doctor

Regulatory & Marketing

Labeler Name
Church & Dwight Co., Inc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10237-271). Click a package code to view its specific billing and regulatory data.

10237-271-04
1 TUBE in 1 CARTON / 113 g in 1 TUBE
10237-271-24
2 TUBE in 1 CARTON / 113 g in 1 TUBE

* 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 10237-271-07 identifies a specific commercial package of 1 tube in 1 carton / 19 g in 1 tube of Therabreath Healthy Gums, a human over the counter drug labeled by Church & Dwight Co., Inc.. This paste, dentifrice is formulated for oral use and contains stannous 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 Church & Dwight Co., Inc. on August 01, 2025. The current certification is valid through December 31, 2026.

How is this Church & Dwight Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10237027107. 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)
10237-271-07
11-Digit CMS (5-4-2)
10237-0271-07

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