Onetouch Revolution
NDC Package 62565-802-01

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.

Onetouch Revolution is adults and children 12 years and over. Marketed by Hager Worldwide, Inc., this product is identified by NDC 62565-802 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
62565-802-01
Package Description
32 g in 1 JAR
Product Code
62565-802
11-Digit Billing Format
62565080201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Onetouch Revolution Topical Anesthetic
Dosage Form
-
Usage Information
Adults and children 12 years and over. Press top of container and dispense 0.2 mL. Apply 0.2 mL of gel to the desired area using a cotton swab. Children under 12 should be supervised by an adult. Children under 2 years of age, consult a doctor.

Regulatory & Marketing

Labeler Name
Hager Worldwide, Inc.
FDA Application #
part356
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
05-05-2017
Listing Expiration
12-31-2019
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 62565-802-01 identifies a specific commercial package of 32 g in 1 jar of Onetouch Revolution Topical Anesthetic, labeled by Hager Worldwide, 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 Hager Worldwide, Inc. on May 05, 2017. The current certification is valid through December 31, 2019.

How is this Hager Worldwide, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62565080201. 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)
62565-802-01
11-Digit CMS (5-4-2)
62565-0802-01

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