Hand Sanitizer Plus Holder Liquid
NDC Package 78164-101-35

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

Package Information

Hand Sanitizer Plus Holder (benzalkonium chloride) liquids is -Adults and children 2 years and over.-Rub on hands for 30 seconds and allow skin to dry.-Children under 2 years.-Ask a doctor before use. This formulation utilizes a liquid delivery system. Marketed by Gertex Hosiery, this product is identified by NDC 78164-101 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
78164-101-35
Package Description
35 mL in 1 BOTTLE
Product Code
78164-101
11-Digit Billing Format
78164010135

Clinical Specifications

Proprietary Name
Hand Sanitizer Plus Holder
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 g/mL
Usage Information
-Adults and children 2 years and over.-Rub on hands for 30 seconds and allow skin to dry.-Children under 2 years.-Ask a doctor before use.

Regulatory & Marketing

Labeler Name
Gertex Hosiery
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2025
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 78164-101-35 identifies a specific commercial package of 35 ml in 1 bottle of Hand Sanitizer Plus Holder, a human over the counter drug labeled by Gertex Hosiery. 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 Gertex Hosiery on September 01, 2025. The current certification is valid through December 31, 2026.

How is this Gertex Hosiery product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78164010135. 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)
78164-101-35
11-Digit CMS (5-4-2)
78164-0101-35

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