Headache Relief Tablet
NDC Package 54973-4008-1

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

Package Information

Headache Relief (atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root) tablets is adults and children12 years and overDissolve 2 tablets under tongue every 15 minutesup to 4 doses, then every 4 hours until relieved.Children under 12 yearsConsult a physician. This formulation utilizes a tablet delivery system. Marketed by Hyland's Inc., this product is identified by NDC 54973-4008.

Identification & Billing

NDC Package Code
54973-4008-1
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
54973-4008
11-Digit Billing Format
54973400801

Clinical Specifications

Proprietary Name
Headache Relief
Non-Proprietary Name
Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac And Iris Versicolor Root
Substance Name
Atropa Belladonna; Gelsemium Sempervirens Root; Ipecac; Iris Versicolor Root
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Adults and children12 years and overDissolve 2 tablets under tongue every 15 minutesup to 4 doses, then every 4 hours until relieved.Children under 12 yearsConsult a physician.

Regulatory & Marketing

Labeler Name
Hyland's 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
04-03-2020
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 54973-4008-1 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Headache Relief, a human over the counter drug labeled by Hyland's Inc.. This tablet is formulated for oral use and contains atropa belladonna; gelsemium sempervirens root; ipecac; iris versicolor root 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 Hyland's Inc. on April 03, 2020. The current certification is valid through December 31, 2026.

How is this Hyland's Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54973400801. 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)
54973-4008-1
11-Digit CMS (5-4-2)
54973-4008-01

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