Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Mint Fluoride Rinse
NDC Package 0126-0032-46

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

Package Information

Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Mint Fluoride (sodium fluoride) rinses 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. This formulation utilizes a rinse delivery system. Marketed by Colgate Oral Pharmaceuticals, Inc., this product is identified by NDC 0126-0032 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
0126-0032-46
Package Description
500 mL in 1 BOTTLE
Product Code
0126-0032
11-Digit Billing Format
00126003246
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Mint Fluoride
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 2 mg/10mL
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
Colgate Oral Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-12-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0126-0032-46 identifies a specific commercial package of 500 ml in 1 bottle of Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Mint Fluoride, a human over the counter drug labeled by Colgate Oral Pharmaceuticals, Inc.. This rinse 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 Oral Pharmaceuticals, Inc. on January 12, 2011. The current certification is valid through December 31, 2026.

How is this Colgate Oral Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00126003246. 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 (4-4-2)
0126-0032-46
11-Digit CMS (5-4-2)
00126-0032-46

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