Hand Sanitizer
NDC Package 79861-005-38

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hand Sanitizer is for occasional and personal domestic use, spray on the palm of hands and rub together for 30 seconds. Marketed by Sanihealth Labs Inc., this product is identified by NDC 79861-005 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
79861-005-38
Package Description
38 mL in 1 BOTTLE
Product Code
79861-005
11-Digit Billing Format
79861000538

Clinical Specifications

Proprietary Name
Hand Sanitizer
Dosage Form
-
Usage Information
For occasional and personal domestic use, spray on the palm of hands and rub together for 30 seconds. Allow to dry. Supervise children when they use this product.

Regulatory & Marketing

Labeler Name
Sanihealth Labs Inc.
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
09-13-2021
Listing Expiration
12-31-2022
Exclude Flag
I
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 79861-005-38 identifies a specific commercial package of 38 ml in 1 bottle of Hand Sanitizer, labeled by Sanihealth Labs Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sanihealth Labs Inc. on September 13, 2021. The current certification is valid through December 31, 2022.

How is this Sanihealth Labs Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79861000538. 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)
79861-005-38
11-Digit CMS (5-4-2)
79861-0005-38

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