NDC Package 76357-411-10 Smartmouth Mouth Sore Zinc Activated Formula

Menthol,Unspecified Form Kit - View Billable Units, 11-Digit Format, RxNorm

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:
76357-411-10
Package Description:
1 KIT in 1 CELLO PACK * 138 mL in 1 BOTTLE, PLASTIC * 138 mL in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Smartmouth Mouth Sore Zinc Activated Formula
Non-Proprietary Name:
Menthol, Unspecified Form
Usage Information:
Adults and children 12 years of age & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.Children 6 years to under 12 years of age should be supervised in the use of this product.Children under 6 years of age: do not use.
11-Digit NDC Billing Format:
76357041110
NDC to RxNorm Crosswalk:
  • RxCUI: 2108024 - menthol 0.2 % Mouthwash
  • RxCUI: 2108024 - menthol 2 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:
    01-01-2022
    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 76357-411-10?

    The NDC Packaged Code 76357-411-10 is assigned to a package of 1 kit in 1 cello pack * 138 ml in 1 bottle, plastic * 138 ml in 1 bottle, plastic of Smartmouth Mouth Sore 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 76357-411 included in the NDC Directory?

    Yes, Smartmouth Mouth Sore Zinc Activated Formula with product code 76357-411 is active and included in the NDC Directory. The product was first marketed by Triumph Pharmaceuticals Inc. on January 01, 2022 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 76357-411-10?

    The 11-digit format is 76357041110. 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
    5-3-276357-411-105-4-276357-0411-10