Peroxy Shield Mouth Sore Rinse
NDC Package 55346-3501-2

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

Peroxy Shield Mouth Sore (1.5% hydrogen peroxide) rinses is for adults and children under 2 years of age or older: rinse one pump (15mL) around in the mouth over the affected area for at least 1 minute, then spit out.Use up to 4 times daily after meals and at bedtime, or as directed by a dentist or physician. This formulation utilizes a rinse delivery system. Marketed by Dental Technologies, Inc., this product is identified by NDC 55346-3501 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
55346-3501-2
Package Description
473 mL in 1 BOTTLE
Product Code
55346-3501
11-Digit Billing Format
55346350102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Peroxy Shield Mouth Sore
Non-Proprietary Name
1.5% Hydrogen Peroxide
Substance Name
Hydrogen Peroxide
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROGEN PEROXIDE 1.5 mL/100mL
Usage Information
For adults and children under 2 years of age or older: rinse one pump (15mL) around in the mouth over the affected area for at least 1 minute, then spit out.Use up to 4 times daily after meals and at bedtime, or as directed by a dentist or physician.

Regulatory & Marketing

Labeler Name
Dental Technologies, Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-03-2020
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 (55346-3501). Click a package code to view its specific billing and regulatory data.

55346-3501-1
1863 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 55346-3501-2 identifies a specific commercial package of 473 ml in 1 bottle of Peroxy Shield Mouth Sore, a human over the counter drug labeled by Dental Technologies, Inc.. This rinse is formulated for oral 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 Dental Technologies, Inc. on June 03, 2020. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55346350102. 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 (5-4-1)
55346-3501-2
11-Digit CMS (5-4-2)
55346-3501-02

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