Therabreath Deep Clean Fresh Mint Rinse
NDC Package 10237-261-16

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 Deep Clean Fresh Mint (cetylpyridinium chloride) rinses is adults and children 12 years and oldervigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. This formulation utilizes a rinse delivery system. Marketed by Church & Dwight Co., Inc., this product is identified by NDC 10237-261 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
10237-261-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
10237-261
11-Digit Billing Format
10237026116
RxNorm Crosswalk
  • RxCUI: 1251772 - cetylpyridinium chloride 0.1 % Mucous Membrane Topical Solution
  • RxCUI: 1251772 - cetylpyridinium chloride 1 MG/ML Mucous Membrane Topical Solution

Clinical Specifications

Proprietary Name
Therabreath Deep Clean Fresh Mint
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE 20 mg/20mL
Usage Information
Adults and children 12 years and oldervigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow rinse.children 6 years to under 12 yearssupervise usechildren under 6 yearsdo not use adults and children 12 years and oldervigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.children 6 years to under 12 yearssupervise usechildren under 6 yearsdo not use

Regulatory & Marketing

Labeler Name
Church & Dwight Co., Inc.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-30-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10237-261). Click a package code to view its specific billing and regulatory data.

10237-261-01
1000 mL in 1 BOTTLE, PLASTIC
10237-261-03
88.7 mL in 1 BOTTLE, PLASTIC
10237-261-26
2 BOTTLE, PLASTIC in 1 PACKAGE / 473 mL in 1 BOTTLE, PLASTIC

* 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 10237-261-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Therabreath Deep Clean Fresh Mint, a human over the counter drug labeled by Church & Dwight Co., Inc.. This rinse is formulated for oral use and contains cetylpyridinium chloride 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 June 30, 2023. 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: 10237026116. 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)
10237-261-16
11-Digit CMS (5-4-2)
10237-0261-16

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