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  5. NDC Package Code: 53462-275-60 Antiplaque Solution

NDC Package 53462-275-60 Antiplaque Solution

Cetylpyridinium Chloride Mouthwash Buccal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
53462-275-60
Package Description:
7 mL in 1 PACKET
Product Code:
53462-275
Proprietary Name:
Antiplaque Solution
Non-Proprietary Name:
Cetylpyridinium Chloride
Substance Name:
Cetylpyridinium Chloride
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.
11-Digit NDC Billing Format:
53462027560
NDC to RxNorm Crosswalk:
  • RxCUI: 1251617 - cetylpyridinium chloride 0.05 % Mouthwash
  • RxCUI: 1251617 - cetylpyridinium chloride 0.5 MG/ML Mouthwash
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Sage Products Llc
    Dosage Form:
    Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
    Administration Route(s):
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
    • Active Ingredient(s):
  • CETYLPYRIDINIUM CHLORIDE .5 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    part356
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    01-09-2009
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 53462-275-60?

    The NDC Packaged Code 53462-275-60 is assigned to a package of 7 ml in 1 packet of Antiplaque Solution, a human over the counter drug labeled by Sage Products Llc. The product's dosage form is mouthwash and is administered via buccal form.

    Is NDC 53462-275 included in the NDC Directory?

    Yes, Antiplaque Solution with product code 53462-275 is active and included in the NDC Directory. The product was first marketed by Sage Products Llc on January 09, 2009 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 53462-275-60?

    The 11-digit format is 53462027560. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253462-275-605-4-253462-0275-60