Headache Tonic Liquid
NDC Package 43857-0507-1

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

Package Information

Headache Tonic (carduus marianus, pyrethrum parthenium, secale cornutum, aconitum napellus, belladonna, bryonia (alba), gelsemium sempervirens, glonoinum, melilotus officinalis, nux vomica, sepia, spigelia anthelmia) liquids is for temporary relief of throbbing headache with muscular soreness of neck & shoulder pain & fullness, especially in the forehead, occiput and temples, & bursting, splitting headache. This formulation utilizes a liquid delivery system. Marketed by Bioactive Nutritional, Inc., this product is identified by NDC 43857-0507.

Identification & Billing

NDC Package Code
43857-0507-1
Package Description
60 mL in 1 BOTTLE, DROPPER
Product Code
43857-0507
11-Digit Billing Format
43857050701

Clinical Specifications

Proprietary Name
Headache Tonic
Non-Proprietary Name
Carduus Marianus, Pyrethrum Parthenium, Secale Cornutum, Aconitum Napellus, Belladonna, Bryonia (alba), Gelsemium Sempervirens, Glonoinum, Melilotus Officinalis, Nux Vomica, Sepia, Spigelia Anthelmia
Substance Name
Aconitum Napellus Whole; Atropa Belladonna; Bryonia Alba Root; Claviceps Purpurea Sclerotium; Gelsemium Sempervirens Root; Melilotus Officinalis Top; Milk Thistle; Nitroglycerin; Sepia Officinalis Juice; Spigelia Anthelmia Whole; Strychnos Nux-vomica Seed; Tanacetum Parthenium Whole
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
For temporary relief of throbbing headache with muscular soreness of neck & shoulder pain & fullness, especially in the forehead, occiput and temples, & bursting, splitting headache. For temporary relief of throbbing headache with muscular soreness of neck & shoulder pain & fullness, especially in the forehead, occiput and temples, & bursting, splitting headache.

Regulatory & Marketing

Labeler Name
Bioactive Nutritional, 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
04-30-2019
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 43857-0507-1 identifies a specific commercial package of 60 ml in 1 bottle, dropper of Headache Tonic, a human over the counter drug labeled by Bioactive Nutritional, Inc.. This liquid is formulated for oral use and contains aconitum napellus whole; atropa belladonna; bryonia alba root; claviceps purpurea sclerotium; gelsemium sempervirens root; melilotus officinalis top; milk thistle; nitroglycerin; sepia officinalis juice; spigelia anthelmia whole; strychnos nux-vomica seed; tanacetum parthenium 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 Bioactive Nutritional, Inc. on April 30, 2019. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43857050701. 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)
43857-0507-1
11-Digit CMS (5-4-2)
43857-0507-01

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