Cavity Protection Fresh Mint Anticavity Mouthwash
NDC Package 63615-001-01

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

Cavity Protection Fresh Mint Anticavity Mouthwash (sodium fluoride) mouthwashes is shake well before using. This formulation utilizes a mouthwash delivery system. Marketed by Oxyfresh Worldwide Inc, this product is identified by NDC 63615-001 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
63615-001-01
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
63615-001
11-Digit Billing Format
63615000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cavity Protection Fresh Mint Anticavity Mouthwash
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .5 mg/mL
Usage Information
Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.

Regulatory & Marketing

Labeler Name
Oxyfresh Worldwide Inc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-23-2014
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 (63615-001). Click a package code to view its specific billing and regulatory data.

63615-001-02
3800 mL in 1 JUG

* 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 63615-001-01 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Cavity Protection Fresh Mint Anticavity Mouthwash, a human over the counter drug labeled by Oxyfresh Worldwide Inc. This mouthwash is formulated for oral 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 Oxyfresh Worldwide Inc on May 23, 2014. The current certification is valid through December 31, 2026.

How is this Oxyfresh Worldwide Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63615000101. 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 (5-3-2)
63615-001-01
11-Digit CMS (5-4-2)
63615-0001-01

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