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  5. NDC Package Code: 54473-294-16 Breathaway Mouth Rinse Fresh Mint

NDC Package 54473-294-16 Breathaway Mouth Rinse Fresh Mint

Cetylpyridinium Chloride Mouthwash Topical - 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:
54473-294-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
54473-294
Proprietary Name:
Breathaway Mouth Rinse Fresh Mint
Non-Proprietary Name:
Cetylpyridinium Chloride
Substance Name:
Cetylpyridinium Chloride
Usage Information:
Useshelps prevent gingivitishelps prevent plaque that leads to gingivitis
11-Digit NDC Billing Format:
54473029416
NDC to RxNorm Crosswalk:
  • RxCUI: 1100924 - cetylpyridinium chloride 0.07 % Oral Rinse
  • RxCUI: 1100924 - cetylpyridinium chloride 0.7 MG/ML Mouthwash
  • RxCUI: 1100928 - Breath-Away 0.07 % Oral Rinse
  • RxCUI: 1100928 - cetylpyridinium chloride 0.7 MG/ML Mouthwash [Breath-Away]
  • RxCUI: 1100928 - Breath-Away 0.07 % Mouth Rinse
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Melaleuca, Inc.
    Dosage Form:
    Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
    Administration Route(s):
  • 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 .3394 g/473mL
    • 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:
    05-02-2011
    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 54473-294-16?

    The NDC Packaged Code 54473-294-16 is assigned to a package of 473 ml in 1 bottle of Breathaway Mouth Rinse Fresh Mint, a human over the counter drug labeled by Melaleuca, Inc.. The product's dosage form is mouthwash and is administered via topical form.

    Is NDC 54473-294 included in the NDC Directory?

    Yes, Breathaway Mouth Rinse Fresh Mint with product code 54473-294 is active and included in the NDC Directory. The product was first marketed by Melaleuca, Inc. on May 02, 2011 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 54473-294-16?

    The 11-digit format is 54473029416. 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
    5-3-254473-294-165-4-254473-0294-16