Headache Relief Tablet
NDC 54973-4008

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54973-4008?
  5. Headache Relief Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

Headache Relief (atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Hyland's Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 54973-4008 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54973-4008
Proprietary Name:
Headache Relief
Non-Proprietary Name: [1]
Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac And Iris Versicolor Root
Substance Name: [2]
Atropa Belladonna; Gelsemium Sempervirens Root; Ipecac; Iris Versicolor Root
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Hyland's Inc.
Labeler Code:
54973
Product Label ID:
a58f376e-90ed-d5f5-e053-2a95a90a0442
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
04-03-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape:
ROUND (C48348)
Size(s):
9 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 54973-4008?

The NDC code 54973-4008 is assigned by the FDA to the product Headache Relief. It is commonly known by its generic name, atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root. This pharmaceutical product is labeled by Hyland's Inc. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54973-4008-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ATROPA BELLADONNA 12 [hp_X]/1 - A plant species of the genus ATROPA, family SOLANACEAE that contains ATROPINE; SCOPOLAMINE; BELLADONNA ALKALOIDS and other SOLANACEOUS ALKALOIDS. Some species in this genus are called deadly nightshade which is also a common name for SOLANUM.
  • GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/1
  • IPECAC 6 [hp_X]/1 - A syrup made from the dried rhizomes of two different species, CEPHAELIS ipecacuanha and C. acuminata. They contain EMETINE, cephaeline, psychotrine and other ISOQUINOLINES. Ipecac syrup is used widely as an emetic acting both locally on the gastric mucosa and centrally on the chemoreceptor trigger zone.
  • IRIS VERSICOLOR ROOT 6 [hp_X]/1

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".