Hand Sanitizer
NDC Package 78684-080-01

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 • Spray 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. Marketed by Still Valley Spirits Llc, this product is identified by NDC 78684-080 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
78684-080-01
Package Description
750 mL in 1 BOTTLE
Product Code
78684-080
11-Digit Billing Format
78684008001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hand Sanitizer
Dosage Form
-
Usage Information
• Spray 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
Still Valley Spirits Llc
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
06-15-2020
Listing Expiration
12-31-2021
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 78684-080-01 identifies a specific commercial package of 750 ml in 1 bottle of Hand Sanitizer, labeled by Still Valley Spirits Llc. 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 Still Valley Spirits Llc on June 15, 2020. The current certification is valid through December 31, 2021.

How is this Still Valley Spirits Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78684008001. 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)
78684-080-01
11-Digit CMS (5-4-2)
78684-0080-01

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