Instant Hand Sanitizer
NDC Package 69583-035-01

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.

Instant Hand Sanitizer is rub dime sized amount between hands until dry.For use by children under 6 years, adult supervision is required. Marketed by Fun Zone, Inc., this product is identified by NDC 69583-035 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
69583-035-01
Package Description
35 mL in 1 BOTTLE, PLASTIC
Product Code
69583-035
11-Digit Billing Format
69583003501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Instant Hand Sanitizer
Dosage Form
-
Usage Information
Rub dime sized amount between hands until dry.For use by children under 6 years, adult supervision is required.

Regulatory & Marketing

Labeler Name
Fun Zone, Inc.
FDA Application #
part333E
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
09-04-2020
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 69583-035-01 identifies a specific commercial package of 35 ml in 1 bottle, plastic of Instant Hand Sanitizer, labeled by Fun Zone, 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 Fun Zone, Inc. on September 04, 2020. The current certification is valid through December 31, 2022.

How is this Fun Zone, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69583003501. 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)
69583-035-01
11-Digit CMS (5-4-2)
69583-0035-01

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