Cryo10 Topical Analgesic Gel
NDC Package 83549-000-01

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

Package Information

Cryo10 Topical Analgesic (menthol) gel is adults and children over 12 years: • roll directly onto affected area without the need to rub, massage or bandage • repeat if necessary, but do not apply more than 4 times daily. This formulation utilizes a gel delivery system. Marketed by Element 26 Llc, this product is identified by NDC 83549-000 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83549-000-01
Package Description
88 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
83549-000
11-Digit Billing Format
83549000001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cryo10 Topical Analgesic
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 100 mg/mL
Usage Information
Adults and children over 12 years: • roll directly onto affected area without the need to rub, massage or bandage • repeat if necessary, but do not apply more than 4 times daily. Children 12 years of younger:ask a doctor.

Regulatory & Marketing

Labeler Name
Element 26 Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-26-2023
Listing Expiration
12-31-2026
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 83549-000-01 identifies a specific commercial package of 88 ml in 1 bottle, with applicator of Cryo10 Topical Analgesic, a human over the counter drug labeled by Element 26 Llc. 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 Element 26 Llc on May 26, 2023. The current certification is valid through December 31, 2026.

How is this Element 26 Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83549000001. 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)
83549-000-01
11-Digit CMS (5-4-2)
83549-0000-01

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