Colgate Total Whitening Gel
NDC Package 67659-310-05

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Colgate Total Whitening Gel is supervise children as necessary until capable of using without supervision.adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physicianchildren under 12 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)children under 6 yearsdo not use unless directed by a dentist or a physicianAntiplaque and antigingivitis use not proven in children. Marketed by Team Technologies, Inc, this product is identified by NDC 67659-310 and is authorized under FDA application NDA020231.

Identification & Billing

NDC Package Code
67659-310-05
Package Description
221 g in 1 TUBE
Product Code
67659-310
11-Digit Billing Format
67659031005
RxNorm Crosswalk
  • RxCUI: 894876 - sodium fluoride 0.24 % / triclosan 0.3 % Toothpaste
  • RxCUI: 894876 - sodium fluoride 0.0024 MG/MG / triclosan 0.003 MG/MG Toothpaste
  • RxCUI: 894876 - sodium fluoride 0.24 % (fluoride ion 0.14 % / triclosan 0.3 % ) Toothpaste

Clinical Specifications

Proprietary Name
Colgate Total Whitening Gel
Dosage Form
-
Usage Information
Supervise children as necessary until capable of using without supervision.adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physicianchildren under 12 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)children under 6 yearsdo not use unless directed by a dentist or a physicianAntiplaque and antigingivitis use not proven in children.

Regulatory & Marketing

Labeler Name
Team Technologies, Inc
FDA Application #
NDA020231
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-20-2010
Listing Expiration
12-31-2019
Exclude Flag
I
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 67659-310-05 identifies a specific commercial package of 221 g in 1 tube of Colgate Total Whitening Gel, labeled by Team Technologies, Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Team Technologies, Inc on September 20, 2010. The current certification is valid through December 31, 2019.

How is this Team Technologies, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67659031005. 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)
67659-310-05
11-Digit CMS (5-4-2)
67659-0310-05

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