Sore Mouth Cleanser Mouthwash
NDC Package 0363-0085-34

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

Package Information

Sore Mouth Cleanser (hydrogen peroxide) mouthwashes is adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth 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 pysicialchildren under 12 should be supervised in the use of the productchildren under 2 years of age: consult a dentist or doctor. This formulation utilizes a mouthwash delivery system. Marketed by Walgreen Co., this product is identified by NDC 0363-0085 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
0363-0085-34
Package Description
236 mL in 1 BOTTLE, PLASTIC
Product Code
0363-0085
11-Digit Billing Format
00363008534
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sore Mouth Cleanser
Non-Proprietary Name
Hydrogen Peroxide
Substance Name
Hydrogen Peroxide
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
HYDROGEN PEROXIDE 15 mg/mL
Usage Information
Adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth 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 pysicialchildren under 12 should be supervised in the use of the productchildren under 2 years of age: consult a dentist or doctor

Regulatory & Marketing

Labeler Name
Walgreen Co.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-02-2014
Listing Expiration
12-31-2027
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 0363-0085-34 identifies a specific commercial package of 236 ml in 1 bottle, plastic of Sore Mouth Cleanser, a human over the counter drug labeled by Walgreen Co.. This mouthwash is formulated for topical 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 Walgreen Co. on May 02, 2014. The current certification is valid through December 31, 2027.

How is this Walgreen Co. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363008534. 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)
0363-0085-34
11-Digit CMS (5-4-2)
00363-0085-34

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