Rayo Power Ice Heat Dual Action Gel
NDC Package 83033-1602-1

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

Package Information

Rayo Power Ice Heat Dual Action (menthol) gel is directionsAdults and children 2 years of age and older:Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use. This formulation utilizes a gel delivery system. Marketed by Quimicas Handal De Centroamerica Sa De Cv, this product is identified by NDC 83033-1602 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83033-1602-1
Package Description
1 TUBE, WITH APPLICATOR in 1 BOX / 80 g in 1 TUBE, WITH APPLICATOR
Product Code
83033-1602
11-Digit Billing Format
83033160201

Clinical Specifications

Proprietary Name
Rayo Power Ice Heat Dual Action
Non-Proprietary Name
Menthol
Substance Name
Menthol
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)
MENTHOL 1 g/g
Usage Information
DirectionsAdults and children 2 years of age and older:Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use.

Regulatory & Marketing

Labeler Name
Quimicas Handal De Centroamerica Sa De Cv
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-01-2023
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83033-1602-1 identifies a specific commercial package of 1 tube, with applicator in 1 box / 80 g in 1 tube, with applicator of Rayo Power Ice Heat Dual Action, a human over the counter drug labeled by Quimicas Handal De Centroamerica Sa De Cv. This gel is formulated for topical use and contains menthol 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 Quimicas Handal De Centroamerica Sa De Cv on November 01, 2023. The current certification is valid through December 31, 2027.

How is this Quimicas Handal De Centroamerica Sa De Cv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83033160201. 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 (5-4-1)
83033-1602-1
11-Digit CMS (5-4-2)
83033-1602-01

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