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  5. NDC Package Code: 61041-211-09 Xerostom

NDC Package 61041-211-09 Xerostom

Sodium Fluoride Mouthwash Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
61041-211-09
Package Description:
1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE
Product Code:
61041-211
Proprietary Name:
Xerostom
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Aids in the prevention of dental cavities.
11-Digit NDC Billing Format:
61041021109
Product Type:
Human Otc Drug
Labeler Name:
Bio Cosmetics
Dosage Form:
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .559 mg/mL
  • SODIUM FLUORIDE .559 mg/mL
    • 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:
    11-15-2013
    End Marketing Date:
    10-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61041-211-3115 mL in 1 PACKET

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61041-211-09?

    The NDC Packaged Code 61041-211-09 is assigned to a package of 1 bottle in 1 carton / 250 ml in 1 bottle of Xerostom, a human over the counter drug labeled by Bio Cosmetics. The product's dosage form is mouthwash and is administered via oral form.

    Is NDC 61041-211 included in the NDC Directory?

    Yes, Xerostom with product code 61041-211 is active and included in the NDC Directory. The product was first marketed by Bio Cosmetics on November 15, 2013.

    What is the 11-digit format for NDC 61041-211-09?

    The 11-digit format is 61041021109. 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
    5-3-261041-211-095-4-261041-0211-09