Antiplaque Solution Mouthwash
NDC Package 53462-275-60

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

Package Information

Antiplaque Solution (cetylpyridinium chloride) mouthwashes is before opening, turn package over, burst solution packet with thumbs. This formulation utilizes a mouthwash delivery system. Marketed by Sage Products Llc, this product is identified by NDC 53462-275 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
53462-275-60
Package Description
7 mL in 1 PACKET
Product Code
53462-275
11-Digit Billing Format
53462027560

Clinical Specifications

Proprietary Name
Antiplaque Solution
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Buccal - Administration directed toward the cheek, generally from within the mouth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE .5 mg/mL
Usage Information
Before opening, turn package over, burst solution packet with thumbs. Peel lid to open.Remove Mouth Moisturizer and Applicator Swab.Attach Toothbrush to suction line.Clean teeth and oral cavity for approximately one minute.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard Toothbrush.  Reattach Covered Yankauer to suction line.Place Mouth Moisturizer on Applicator Swab.Apply as needed to lips and inside mouth.Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.Children ages 6 to 12 years: supervise use.Children under 6 years of age: do not use.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity.

Regulatory & Marketing

Labeler Name
Sage Products Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-09-2009
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 53462-275-60 identifies a specific commercial package of 7 ml in 1 packet of Antiplaque Solution, a human over the counter drug labeled by Sage Products Llc. This mouthwash is formulated for buccal 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 Sage Products Llc on January 09, 2009. The current certification is valid through December 31, 2027.

How is this Sage Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53462027560. 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)
53462-275-60
11-Digit CMS (5-4-2)
53462-0275-60

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