Arnica Gel 15 Gel
NDC Package 80004-400-40

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

Package Information

Arnica Gel 15 (arnica gel) gel is apply a thin layer of gel to target area. This formulation utilizes a gel delivery system. Marketed by Vitamedica, Inc., this product is identified by NDC 80004-400.

Identification & Billing

NDC Package Code
80004-400-40
Package Description
1 TUBE in 1 CARTON / 85 g in 1 TUBE
Product Code
80004-400
11-Digit Billing Format
80004040040

Clinical Specifications

Proprietary Name
Arnica Gel 15 Arnica Montana 1x Hpus
Non-Proprietary Name
Arnica Gel
Substance Name
Achillea Millefolium Flower; Arnica Montana Flower; Arnica Montana Whole; Belladonna Leaf; Bellis Perennis Flower; Calendula Officinalis Flowering Top; Hamamelis Virginiana Bark; Hypericum Perforatum; Ledum Palustre Whole; Rhus Typhina Whole; Ruta Graveolens Whole; Symphytum Officinale Whole
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
Apply a thin layer of gel to target area. Reapply 3 times daily or as needed.

Regulatory & Marketing

Labeler Name
Vitamedica, 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
03-01-2024
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 80004-400-40 identifies a specific commercial package of 1 tube in 1 carton / 85 g in 1 tube of Arnica Gel 15 Arnica Montana 1x Hpus, a human over the counter drug labeled by Vitamedica, Inc.. This gel is formulated for topical use and contains achillea millefolium flower; arnica montana flower; arnica montana whole; belladonna leaf; bellis perennis flower; calendula officinalis flowering top; hamamelis virginiana bark; hypericum perforatum; ledum palustre whole; rhus typhina whole; ruta graveolens whole; symphytum officinale whole 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 Vitamedica, Inc. on March 01, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80004040040. 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)
80004-400-40
11-Digit CMS (5-4-2)
80004-0400-40

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