Enriched Foam Alcohol-free Hand Sanitizer Liquid
NDC Package 65321-039-01

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

Package Information

Enriched Foam Alcohol-free Hand Sanitizer (benzalkonium chloride) liquids is place hands under the dispenser, allow 0.4 mL of foam into hands, rub thoroughly over the surface of both hands for at least 30 seconds, and then allow hands dry. This formulation utilizes a liquid delivery system. Marketed by Rubbermaid Commercial Products Llc, this product is identified by NDC 65321-039 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
65321-039-01
Package Description
4 POUCH in 1 BOX / 1100 mL in 1 POUCH
Product Code
65321-039
11-Digit Billing Format
65321003901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Enriched Foam Alcohol-free Hand 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 13 mg/100mL
Usage Information
Place hands under the dispenser, allow 0.4 mL of foam into hands, rub thoroughly over the surface of both hands for at least 30 seconds, and then allow hands dry

Regulatory & Marketing

Labeler Name
Rubbermaid Commercial Products Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-21-2021
Listing Expiration
12-31-2027
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 65321-039-01 identifies a specific commercial package of 4 pouch in 1 box / 1100 ml in 1 pouch of Enriched Foam Alcohol-free Hand Sanitizer, a human over the counter drug labeled by Rubbermaid Commercial Products Llc. 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 Rubbermaid Commercial Products Llc on June 21, 2021. The current certification is valid through December 31, 2027.

How is this Rubbermaid Commercial Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65321003901. 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)
65321-039-01
11-Digit CMS (5-4-2)
65321-0039-01

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