Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
NDC Package 67659-034-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride is adults and children 6 years of age and olderuse once a day after brushing your teeth with a toothpastevigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervisionchildren under 6 years of ageask a dentist or physician. Marketed by Team Technologies, Inc., this product is identified by NDC 67659-034 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
67659-034-30
Package Description
100 mL in 1 BOTTLE
Product Code
11-Digit Billing Format
67659003430
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
Dosage Form
-
Usage Information
Adults and children 6 years of age and olderuse once a day after brushing your teeth with a toothpastevigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervisionchildren under 6 years of ageask a dentist or physician

Regulatory & Marketing

Labeler Name
Team Technologies, Inc.
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-01-2017
Listing Expiration
12-31-2020
Exclude Flag
I
Sample Package
No

Hierarchy Structure

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 67659-034-30 identifies a specific commercial package of 100 ml in 1 bottle of Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride, 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 August 01, 2017. The current certification is valid through December 31, 2020.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67659003430. 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)
67659-034-30
11-Digit CMS (5-4-2)
67659-0034-30

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