Instant Hand Antiseptic Gel
NDC Package 59448-003-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Instant Hand Antiseptic (benzalkonium chloride) gel is 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. This formulation utilizes a gel delivery system. Marketed by Asp Global, this product is identified by NDC 59448-003 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
59448-003-01
Package Description
53 mL in 1 BOTTLE, PLASTIC
Product Code
59448-003
11-Digit Billing Format
59448000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Instant Hand Antiseptic
Non-Proprietary Name
Benzalkonium Chloride
Substance Name
Benzalkonium Chloride
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
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
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.

Regulatory & Marketing

Labeler Name
Asp Global
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-27-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59448-003-01 identifies a specific commercial package of 53 ml in 1 bottle, plastic of Instant Hand Antiseptic, a human over the counter drug labeled by Asp Global. This gel is formulated for topical use and contains benzalkonium chloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Asp Global on November 27, 2018. The current certification is valid through December 31, 2026.

How is this Asp Global product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59448000301. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59448-003-01
11-Digit CMS (5-4-2)
59448-0003-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.