Cph Anti-bacterial Breath Mist Spray
NDC Package 63645-179-06

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

Package Information

Cph Anti-bacterial Breath Mist (cetylpyridinium chloride) sprays is adults and children 12 years of age and older: Spray 3 times in the oral cavity. This formulation utilizes a spray delivery system. Marketed by Oralabs, this product is identified by NDC 63645-179 and is authorized under FDA application 356.

Identification & Billing

NDC Package Code
63645-179-06
Package Description
13 mL in 1 BOTTLE
Product Code
63645-179
11-Digit Billing Format
63645017906

Clinical Specifications

Proprietary Name
Cph Anti-bacterial Breath Mist
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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)
CETYLPYRIDINIUM CHLORIDE 1.11 g/13mL
Usage Information
Adults and children 12 years of age and older: Spray 3 times in the oral cavity. Children 6-12 years of age: Supervise use. Children under 6 years: Do not use.

Regulatory & Marketing

Labeler Name
Oralabs
Product Type
Human Otc Drug
FDA Application #
356
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-15-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63645-179-06 identifies a specific commercial package of 13 ml in 1 bottle of Cph Anti-bacterial Breath Mist, a human over the counter drug labeled by Oralabs. This spray is formulated for topical use and contains cetylpyridinium chloride 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 Oralabs on April 15, 2022. The current certification is valid through December 31, 2026.

How is this Oralabs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63645017906. 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)
63645-179-06
11-Digit CMS (5-4-2)
63645-0179-06

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