Traulevium Gel
NDC Package 70857-004-16

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

Package Information

Traulevium (arnica montana, calendula officinalis, hamamelis virginiana, echinacea, echinacea purpurea, chamomilla, symphytum officinale, bellis perennis, hypericum perforatum, millefolium, aconitum napellus, belladonna, mercurius solubilis, hepar sulphuris calcareum.) gel is  Adults and children 4 years and olderApply generously to affected areas 2 to 3 times daily, or more often if necessary. This formulation utilizes a gel delivery system. Marketed by Medical Technology Products, Inc., this product is identified by NDC 70857-004.

Identification & Billing

NDC Package Code
70857-004-16
Package Description
454 g in 1 BOTTLE, PUMP
Product Code
70857-004
11-Digit Billing Format
70857000416

Clinical Specifications

Proprietary Name
Traulevium Pain Relief Gel
Non-Proprietary Name
Arnica Montana, Calendula Officinalis, Hamamelis Virginiana, Echinacea, Echinacea Purpurea, Chamomilla, Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Millefolium, Aconitum Napellus, Belladonna, Mercurius Solubilis, Hepar Sulphuris Calcareum.
Substance Name
Achillea Millefolium; Aconitum Napellus; Arnica Montana; Atropa Belladonna; Bellis Perennis; Calcium Sulfide; Calendula Officinalis Flowering Top; Comfrey Root; Echinacea Purpurea; Echinacea, Unspecified; Hamamelis Virginiana Root Bark/stem Bark; Hypericum Perforatum; Matricaria Recutita; Mercurius Solubilis
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)
Usage Information
 Adults and children 4 years and olderApply generously to affected areas 2 to 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. Children under 4Consult your healthcare provider. 

Regulatory & Marketing

Labeler Name
Medical Technology Products, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
09-19-2016
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 70857-004-16 identifies a specific commercial package of 454 g in 1 bottle, pump of Traulevium Pain Relief Gel, a human over the counter drug labeled by Medical Technology Products, Inc.. This gel is formulated for topical use and contains achillea millefolium; aconitum napellus; arnica montana; atropa belladonna; bellis perennis; calcium sulfide; calendula officinalis flowering top; comfrey root; echinacea purpurea; echinacea, unspecified; hamamelis virginiana root bark/stem bark; hypericum perforatum; matricaria recutita; mercurius solubilis 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 Medical Technology Products, Inc. on September 19, 2016. The current certification is valid through December 31, 2026.

How is this Medical Technology Products, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70857000416. 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)
70857-004-16
11-Digit CMS (5-4-2)
70857-0004-16

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