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  5. NDC Package Code: 59448-003-01 Instant Hand Antiseptic

NDC Package 59448-003-01 Instant Hand Antiseptic

Benzalkonium Chloride Gel Topical - 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:
59448-003-01
Package Description:
53 mL in 1 BOTTLE, PLASTIC
Product Code:
59448-003
Proprietary Name:
Instant Hand Antiseptic
Non-Proprietary Name:
Benzalkonium Chloride
Substance Name:
Benzalkonium Chloride
Usage Information:
Adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician Rub dime sized amount between hands until dry.Children under 6 years of age should be supervised when using this product.
11-Digit NDC Billing Format:
59448000301
NDC to RxNorm Crosswalk:
  • RxCUI: 2048259 - benzalkonium chloride 0.095 % Topical Gel
  • RxCUI: 2048259 - benzalkonium chloride 0.00095 MG/MG Topical Gel
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Asp Global, Llc
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • BENZALKONIUM CHLORIDE .095 mg/100mL
    • Sample Package:
    No
    FDA Application Number:
    part333E
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    11-27-2018
    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 59448-003-01?

    The NDC Packaged Code 59448-003-01 is assigned to a package of 53 ml in 1 bottle, plastic of Instant Hand Antiseptic, a human over the counter drug labeled by Asp Global, Llc. The product's dosage form is gel and is administered via topical form.

    Is NDC 59448-003 included in the NDC Directory?

    Yes, Instant Hand Antiseptic with product code 59448-003 is active and included in the NDC Directory. The product was first marketed by Asp Global, Llc on November 27, 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 59448-003-01?

    The 11-digit format is 59448000301. 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
    5-3-259448-003-015-4-259448-0003-01