Colgate Gel, Dentifrice
NDC Package 35000-430-58

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 (sodium fluoride) gel is adults 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 physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician. This formulation utilizes a gel, dentifrice delivery system. Marketed by Colgate-palmolive Company, this product is identified by NDC 35000-430 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
35000-430-58
Package Description
1 TUBE in 1 CARTON / 70 g in 1 TUBE
Product Code
35000-430
11-Digit Billing Format
35000043058
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Colgate Max Fresh Clean Mint
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 1.1 mg/g
Usage Information
Adults 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 physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician

Regulatory & Marketing

Labeler Name
Colgate-palmolive Company
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-28-2024
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 (35000-430). Click a package code to view its specific billing and regulatory data.

35000-430-95
1 TUBE in 1 CARTON / 179 g in 1 TUBE
35000-430-99
1 TUBE, WITH APPLICATOR in 1 CARTON / 53.8 g in 1 TUBE, WITH APPLICATOR

* 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 35000-430-58 identifies a specific commercial package of 1 tube in 1 carton / 70 g in 1 tube of Colgate Max Fresh Clean Mint, a human over the counter drug labeled by Colgate-palmolive Company. This gel, 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 Colgate-palmolive Company on May 28, 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: 35000043058. 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)
35000-430-58
11-Digit CMS (5-4-2)
35000-0430-58

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