Optimize Thick Hand Sanitizer Gel
NDC Package 68400-486-01

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

Optimize Thick Hand Sanitizer (alcohol) gel is place enough product on hands to cover all surfaces. This formulation utilizes a gel delivery system. Marketed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc, this product is identified by NDC 68400-486 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
68400-486-01
Package Description
3780 mL in 1 BOTTLE, PLASTIC
Product Code
68400-486
11-Digit Billing Format
68400048601

Clinical Specifications

Proprietary Name
Optimize Thick Hand Sanitizer
Non-Proprietary Name
Alcohol
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 70 mL/100mL
Usage Information
Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-30-2020
End Marketing Date
02-19-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68400-486). Click a package code to view its specific billing and regulatory data.

68400-486-06
177.4 mL in 1 BOTTLE, PLASTIC
68400-486-08
236.6 mL in 1 BOTTLE, PLASTIC
68400-486-15
473.2 mL in 1 BOTTLE, PLASTIC
68400-486-16
473.2 mL in 1 BOTTLE, PLASTIC

* 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 68400-486-01 identifies a specific commercial package of 3780 ml in 1 bottle, plastic of Optimize Thick Hand Sanitizer, a human over the counter drug labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. 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 Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc on March 30, 2020.

How is this Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68400048601. 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)
68400-486-01
11-Digit CMS (5-4-2)
68400-0486-01

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