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  5. NDC Package Code: 76357-175-00 Smartmouth Premium Action Smartmouth Advanced Clinical Formula (acf)

NDC Package 76357-175-00 Smartmouth Premium Action Smartmouth Advanced Clinical Formula (acf)

Sodium Monofluorophosphate Paste, Dentifrice Dental - 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:
76357-175-00
Package Description:
96.4 g in 1 TUBE
Product Code:
76357-175
Proprietary Name:
Smartmouth Premium Action Smartmouth Advanced Clinical Formula (acf)
Non-Proprietary Name:
Sodium Monofluorophosphate
Substance Name:
Sodium Monofluorophosphate
Usage Information:
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
76357017500
Product Type:
Human Otc Drug
Labeler Name:
Triumph Pharmaceuticals Inc.
Dosage Form:
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM MONOFLUOROPHOSPHATE 10.21 g/96.4g
    • 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:
    02-01-2018
    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 76357-175-00?

    The NDC Packaged Code 76357-175-00 is assigned to a package of 96.4 g in 1 tube of Smartmouth Premium Action Smartmouth Advanced Clinical Formula (acf), a human over the counter drug labeled by Triumph Pharmaceuticals Inc.. The product's dosage form is paste, dentifrice and is administered via dental form.

    Is NDC 76357-175 included in the NDC Directory?

    Yes, Smartmouth Premium Action Smartmouth Advanced Clinical Formula (acf) with product code 76357-175 is active and included in the NDC Directory. The product was first marketed by Triumph Pharmaceuticals Inc. on February 01, 2018 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 76357-175-00?

    The 11-digit format is 76357017500. 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
    5-3-276357-175-005-4-276357-0175-00