Terrafreeze Pain Relief Cream
NDC Package 71805-855-00

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

Package Information

Terrafreeze Pain Relief (menthol, methyl salicylate, histamine dihydrochloride) cream is adults and children two-years of age or older:  Apply to affected area 3-4 times daily. This formulation utilizes a cream delivery system. Marketed by Beyond Derma, Llc, this product is identified by NDC 71805-855 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
71805-855-00
Package Description
1 PACKAGE in 1 BOX / 57 g in 1 PACKAGE
Product Code
71805-855
11-Digit Billing Format
71805085500
RxNorm Crosswalk
  • RxCUI: 1947261 - histamine dihydrochloride 0.050 % / menthol 10 % / methyl salicylate 10 % Topical Cream
  • RxCUI: 1947261 - histamine dihydrochloride 0.5 MG/ML / menthol 100 MG/ML / methyl salicylate 100 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Terrafreeze Pain Relief
Non-Proprietary Name
Menthol, Methyl Salicylate, Histamine Dihydrochloride
Substance Name
Histamine Dihydrochloride; Menthol; Methyl Salicylate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
Usage Information
Adults and children two-years of age or older:  Apply to affected area 3-4 times daily. Children under two-years of age:  Consult a physician

Regulatory & Marketing

Labeler Name
Beyond Derma, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-12-2017
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 71805-855-00 identifies a specific commercial package of 1 package in 1 box / 57 g in 1 package of Terrafreeze Pain Relief, a human over the counter drug labeled by Beyond Derma, Llc. This cream is formulated for topical use and contains histamine dihydrochloride; menthol; methyl salicylate 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 Beyond Derma, Llc on October 12, 2017. The current certification is valid through December 31, 2026.

How is this Beyond Derma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71805085500. 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)
71805-855-00
11-Digit CMS (5-4-2)
71805-0855-00

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