Homeopathic Stress Mints Lozenge
NDC 57556-004

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57556-004?
  5. Homeopathic Stress Mints Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Homeopathic Stress Mints (agrimonia eupatoria 3x, matricaria chamomilla 12x, arnica montana 12x, phosphoric acid 12x, avena sativa flowering top 3x, strychnos ignatii seed 12x, anemone pulsatilla 12x, aconitum napellus 12x, strychnos nux vomica seed 12x) is a UNAPPROVED DRUG OTHER-approved product labeled by Historical Remedies Llp. This medication is typically used as a allergens [cs]. It is supplied as a white lozenge for oral administration. This product entry covers the primary NDC 57556-004 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
57556-004
Proprietary Name:
Homeopathic Stress Mints
Non-Proprietary Name: [1]
Agrimonia Eupatoria 3x, Matricaria Chamomilla 12x, Arnica Montana 12x, Phosphoric Acid 12x, Avena Sativa Flowering Top 3x, Strychnos Ignatii Seed 12x, Anemone Pulsatilla 12x, Aconitum Napellus 12x, Strychnos Nux Vomica Seed 12x
Substance Name: [2]
Aconitum Napellus; Agrimonia Eupatoria; Arnica Montana Whole; Avena Sativa Flowering Top; Matricaria Chamomilla Whole; Phosphoric Acid; Pulsatilla Vulgaris Whole; Strychnos Ignatii Seed; Strychnos Nux-vomica Seed
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Historical Remedies Llp
Labeler Code:
57556
Product Label ID:
828d0f4d-915e-4340-bb98-62cd17eb970b
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
05-01-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
14 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 57556-004?

The NDC code 57556-004 is assigned by the FDA to the product Homeopathic Stress Mints. It is commonly known by its generic name, agrimonia eupatoria 3x, matricaria chamomilla 12x, arnica montana 12x, phosphoric acid 12x, avena sativa flowering top 3x, strychnos ignatii seed 12x, anemone pulsatilla 12x, aconitum napellus 12x, strychnos nux vomica seed 12x. This pharmaceutical product is labeled by Historical Remedies Llp and is currently categorized as listed product. The medication is a lozenge administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 57556-004-01. 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 children over 8: Dissolve one Stress Mints lozenge in mouth. Repeat every half hour as needed.

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.

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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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".