Mt Royal Hand Sanitizer Gel
NDC Package 74322-004-01

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

Package Information

Mt Royal Hand Sanitizer (70% ethyl alcohol gel) gel is rub hands thoroughly with product and allow to dry. This formulation utilizes a gel delivery system. Marketed by Mount Royal Soaps, Llc, this product is identified by NDC 74322-004 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
74322-004-01
Package Description
.398 kg in 1 BOTTLE, DISPENSING
Product Code
74322-004
11-Digit Billing Format
74322000401

Clinical Specifications

Proprietary Name
Mt Royal Hand Sanitizer
Non-Proprietary Name
70% Ethyl Alcohol Gel
Substance Name
Alcohol
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)
ALCOHOL 1306 kg/2100kg
Usage Information
Rub hands thoroughly with product and allow to dry.

Regulatory & Marketing

Labeler Name
Mount Royal Soaps, Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2025
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 74322-004-01 identifies a specific commercial package of .398 kg in 1 bottle, dispensing of Mt Royal Hand Sanitizer, a human over the counter drug labeled by Mount Royal Soaps, Llc. This gel is formulated for topical use and contains alcohol 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 Mount Royal Soaps, Llc on May 01, 2025. The current certification is valid through December 31, 2027.

How is this Mount Royal Soaps, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 74322000401. 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)
74322-004-01
11-Digit CMS (5-4-2)
74322-0004-01

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