Gentlecare Hand And Skin Sanitizer Liquid
NDC Package 78181-020-07

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

Package Information

Gentlecare Hand And Skin Sanitizer (benzalkonium chloride) liquids is uses■ For sanitizing to reduce bacteria on the skin. This formulation utilizes a liquid delivery system. Marketed by Paragon Solutions Us, Inc., this product is identified by NDC 78181-020 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
78181-020-07
Package Description
221 mL in 1 BOTTLE, PUMP
Product Code
78181-020
11-Digit Billing Format
78181002007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gentlecare Hand And Skin Sanitizer
Non-Proprietary Name
Benzalkonium Chloride
Substance Name
Benzalkonium Chloride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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 1.3 mg/mL
Usage Information
Uses■ For sanitizing to reduce bacteria on the skin.

Regulatory & Marketing

Labeler Name
Paragon Solutions Us, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (78181-020). Click a package code to view its specific billing and regulatory data.

78181-020-02
50 mL in 1 BOTTLE, PUMP
78181-020-18
550 mL in 1 BOTTLE, PUMP
78181-020-28
3785 mL in 1 JUG

* 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 78181-020-07 identifies a specific commercial package of 221 ml in 1 bottle, pump of Gentlecare Hand And Skin Sanitizer, a human over the counter drug labeled by Paragon Solutions Us, Inc.. This liquid 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 Paragon Solutions Us, Inc. on April 01, 2020. The current certification is valid through December 31, 2026.

How is this Paragon Solutions Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78181002007. 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)
78181-020-07
11-Digit CMS (5-4-2)
78181-0020-07

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