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  5. NDC Package Code: 76357-509-01 Smartmouth Smartmouth Gum Health Zinc Activated Formula

NDC Package 76357-509-01 Smartmouth Smartmouth Gum Health Zinc Activated Formula

Cetylpyridinium Chloride Kit - 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:
76357-509-01
Package Description:
1 KIT in 1 BOTTLE * 237 mL in 1 BOTTLE * 237 mL in 1 BOTTLE (76357-599-02)
Product Code:
76357-509
Proprietary Name:
Smartmouth Smartmouth Gum Health Zinc Activated Formula
Non-Proprietary Name:
Cetylpyridinium Chloride
Usage Information:
Use after your normal brushing and flossing routineAdults and children 12 years of age & older: vigorously swish 20 mL of rinse (pour to indicator line on cap) twice a day for 30 seconds and then spit out. Do not swallow.Children 6 years to under 12 years of age: supervise use.Children under 6 years of age: do not use unless directed by a healthcare professional.
11-Digit NDC Billing Format:
76357050901
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:
    Triumph Pharmaceuticals, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    M022
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    01-01-2024
    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 76357-509-01?

    The NDC Packaged Code 76357-509-01 is assigned to a package of 1 kit in 1 bottle * 237 ml in 1 bottle * 237 ml in 1 bottle (76357-599-02) of Smartmouth Smartmouth Gum Health Zinc Activated Formula, a human over the counter drug labeled by Triumph Pharmaceuticals, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 76357-509 included in the NDC Directory?

    Yes, Smartmouth Smartmouth Gum Health Zinc Activated Formula with product code 76357-509 is active and included in the NDC Directory. The product was first marketed by Triumph Pharmaceuticals, Inc. on January 01, 2024 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 76357-509-01?

    The 11-digit format is 76357050901. 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
    5-3-276357-509-015-4-276357-0509-01