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  5. NDC Package Code: 53462-175-60 Antiseptic Oral Rinse

NDC Package 53462-175-60 Antiseptic Oral Rinse

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:
53462-175-60
Package Description:
7 mL in 1 PACKET
Product Code:
53462-175
Proprietary Name:
Antiseptic Oral Rinse
Non-Proprietary Name:
Cetylpyridinium Chloride
Substance Name:
Cetylpyridinium Chloride
Usage Information:
Use up to 4 times daily or as directed by a dentist or doctor.Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette ® Oral Swab.  Instruct to expectorate. Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.
11-Digit NDC Billing Format:
53462017560
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:
    06-21-2000
    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 53462-175-60?

    The NDC Packaged Code 53462-175-60 is assigned to a package of 7 ml in 1 packet of Antiseptic Oral Rinse, 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 53462-175 included in the NDC Directory?

    Yes, Antiseptic Oral Rinse with product code 53462-175 is active and included in the NDC Directory. The product was first marketed by Sage Products Llc on June 21, 2000 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 53462-175-60?

    The 11-digit format is 53462017560. 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
    5-3-253462-175-605-4-253462-0175-60