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  5. NDC Package Code: 54473-301-04 Whitening Tooth Polish

NDC Package 54473-301-04 Whitening Tooth Polish

Sodium Fluoride Paste 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:
54473-301-04
Package Description:
108 g in 1 TUBE
Product Code:
54473-301
Proprietary Name:
Whitening Tooth Polish
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Use aids in the prevention of dental cavities
11-Digit NDC Billing Format:
54473030104
NDC to RxNorm Crosswalk:
  • RxCUI: 891775 - sodium fluoride 0.243 % Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Melaleuca, Inc.
    Dosage Form:
    Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    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):
  • SODIUM FLUORIDE .26244 g/108g
    • Sample Package:
    No
    FDA Application Number:
    part355
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    04-01-2010
    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 54473-301-04?

    The NDC Packaged Code 54473-301-04 is assigned to a package of 108 g in 1 tube of Whitening Tooth Polish, a human over the counter drug labeled by Melaleuca, Inc.. The product's dosage form is paste and is administered via topical form.

    Is NDC 54473-301 included in the NDC Directory?

    Yes, Whitening Tooth Polish with product code 54473-301 is active and included in the NDC Directory. The product was first marketed by Melaleuca, Inc. on April 01, 2010 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 54473-301-04?

    The 11-digit format is 54473030104. 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
    5-3-254473-301-045-4-254473-0301-04