NDC Package 55346-3501-1 Peroxy Shield Mouth Sore

1.5% Hydrogen Peroxide Rinse Oral - View Billable Units, 11-Digit Format, RxNorm

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Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

55346-3501-1

Package Description:

1863 mL in 1 BOTTLE, PLASTIC

Product Code:

55346-3501

Proprietary Name:

Peroxy Shield Mouth Sore

Non-Proprietary Name:

1.5% Hydrogen Peroxide

Substance Name:

Hydrogen Peroxide

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.

11-Digit NDC Billing Format:

55346350101

NDC to RxNorm Crosswalk:

RxCUI: 199011 - hydrogen peroxide 1.5 % Oral Solution

RxCUI: 199011 - hydrogen peroxide 15 MG/ML Oral Solution

RxCUI: 2480895 - PEROXY SHIELD 1.5 % Oral Solution

RxCUI: 2480895 - hydrogen peroxide 15 MG/ML Oral Solution [Peroxy Shield]

RxCUI: 2480895 - Peroxy Shield 1.5 % Oral Solution

Product Type:

Human Otc Drug

Labeler Name:

Dental Technologies, Inc.

Dosage Form:

Rinse - A liquid used to cleanse by flushing.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

HYDROGEN PEROXIDE 1.5 mL/100mL

Sample Package:

FDA Application Number:

M022

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

06-03-2020

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

55346 - Dental Technologies, Inc.
- 55346-3501 - Peroxy Shield Mouth Sore
  - 55346-3501-1 - 1863 mL in 1 BOTTLE, PLASTIC

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.

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Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
55346-3501-2	473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 55346-3501-1?

The NDC Packaged Code 55346-3501-1 is assigned to a package of 1863 ml in 1 bottle, plastic of Peroxy Shield Mouth Sore, a human over the counter drug labeled by Dental Technologies, Inc.. The product's dosage form is rinse and is administered via oral form.

Is NDC 55346-3501 included in the NDC Directory?

Yes, Peroxy Shield Mouth Sore with product code 55346-3501 is active and included in the NDC Directory. The product was first marketed by Dental Technologies, Inc. on June 03, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 55346-3501-1?

The 11-digit format is 55346350101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	55346-3501-1	5-4-2	55346-3501-01

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