Colgate Total Active Prevention Spearmint Rinse
NDC Package 35000-280-16

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

Colgate Total Active Prevention Spearmint (cetylpyridinium chloride) rinses is adults and children 12 years of age and oldervigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. This formulation utilizes a rinse delivery system. Marketed by Colgate-palmolive Company, this product is identified by NDC 35000-280 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
35000-280-16
Package Description
500 mL in 1 BOTTLE
Product Code
35000-280
11-Digit Billing Format
35000028016
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Colgate Total Active Prevention Spearmint
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE 15 mg/20mL
Usage Information
Adults and children 12 years of age and oldervigorously swish 20 mL 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 years of agesupervise usechildren under 6 years of agedo not use

Regulatory & Marketing

Labeler Name
Colgate-palmolive Company
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-31-2024
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 (35000-280). Click a package code to view its specific billing and regulatory data.

35000-280-31
1000 mL in 1 BOTTLE

* 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 35000-280-16 identifies a specific commercial package of 500 ml in 1 bottle of Colgate Total Active Prevention Spearmint, a human over the counter drug labeled by Colgate-palmolive Company. This rinse is formulated for dental 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 Colgate-palmolive Company on October 31, 2024. The current certification is valid through December 31, 2026.

How is this Colgate-palmolive Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35000028016. 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)
35000-280-16
11-Digit CMS (5-4-2)
35000-0280-16

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