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  5. NDC Package Code: 16571-823-10 Denta 5000 Plus Sensitive

NDC Package 16571-823-10 Denta 5000 Plus Sensitive

Sodium Fluoride And Potassium Nitrate Gel, 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:
16571-823-10
Package Description:
100 mL in 1 TUBE
Product Code:
16571-823
Proprietary Name:
Denta 5000 Plus Sensitive
Non-Proprietary Name:
Sodium Fluoride And Potassium Nitrate
Substance Name:
Potassium Nitrate; Sodium Fluoride
Usage Information:
A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Denta 5000 Plus Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
11-Digit NDC Billing Format:
16571082310
Product Type:
Human Prescription Drug
Labeler Name:
Rising Pharma Holdings, Inc.
Dosage Form:
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • POTASSIUM NITRATE 57.5 mg/mL
  • SODIUM FLUORIDE 5.8 mg/mL
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    02-14-2024
    Listing Expiration Date:
    12-31-2025
    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 16571-823-10?

    The NDC Packaged Code 16571-823-10 is assigned to a package of 100 ml in 1 tube of Denta 5000 Plus Sensitive, a human prescription drug labeled by Rising Pharma Holdings, Inc.. The product's dosage form is gel, dentifrice and is administered via dental form.

    Is NDC 16571-823 included in the NDC Directory?

    Yes, Denta 5000 Plus Sensitive with product code 16571-823 is active and included in the NDC Directory. The product was first marketed by Rising Pharma Holdings, Inc. on February 14, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 16571-823-10?

    The 11-digit format is 16571082310. 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
    5-3-216571-823-105-4-216571-0823-10