Peroxyl Mouth Sore Mild Mint Rinse
NDC Package 0126-0083-22

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

Peroxyl Mouth Sore Mild Mint (hydrogen peroxide) rinses is adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) around in the mouth over affected area for at least 1 minute, then spit outUse up to 4 times daily after meals and at bedtime or as directed by a dentist or physicianChildren under 12 years of age should be supervised in the use of the productChildren under 2 years of age: consult a dentist or physician. This formulation utilizes a rinse delivery system. Marketed by Colgate Oral Pharmaceuticals Inc., this product is identified by NDC 0126-0083 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
0126-0083-22
Package Description
1000 mL in 1 BOTTLE
Product Code
0126-0083
11-Digit Billing Format
00126008322
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Peroxyl Mouth Sore Mild Mint
Non-Proprietary Name
Hydrogen Peroxide
Substance Name
Hydrogen Peroxide
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Buccal - Administration directed toward the cheek, generally from within the mouth.
Active Ingredient(s)
HYDROGEN PEROXIDE 15 mg/mL
Usage Information
Adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) around in the mouth over affected area for at least 1 minute, then spit outUse up to 4 times daily after meals and at bedtime or as directed by a dentist or physicianChildren under 12 years of age should be supervised in the use of the productChildren under 2 years of age: consult a dentist or physician

Regulatory & Marketing

Labeler Name
Colgate Oral Pharmaceuticals Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2009
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 (0126-0083). Click a package code to view its specific billing and regulatory data.

0126-0083-16
500 mL in 1 BOTTLE, PLASTIC
0126-0083-31
946 mL in 1 BOTTLE
0126-0083-70
50 POUCH in 1 CARTON / 10 mL in 1 POUCH
0126-0083-99
250 mL in 1 BOTTLE, PLASTIC

* 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 0126-0083-22 identifies a specific commercial package of 1000 ml in 1 bottle of Peroxyl Mouth Sore Mild Mint, a human over the counter drug labeled by Colgate Oral Pharmaceuticals Inc.. This rinse is formulated for buccal use and contains hydrogen peroxide 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 01, 2009. 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: 00126008322. 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)
0126-0083-22
11-Digit CMS (5-4-2)
00126-0083-22

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