Homeopathic Calm Drops Lozenge
NDC 57556-006

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57556-006?
  5. Homeopathic Calm Drops Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Homeopathic Calm Drops (arsenic trioxide 30c, matricaria chamomilla12x, arabica coffee bean 30x, potassium carbonate30c, strychnos ignatii seed30x, lachesis muta venom12x, phosphoric acid 3x, anemone pulsatilla 12c, valerian 30c, aconitum napellus 6x, chloride ion 12x, strychnos nux-vomica seed 30c) is a UNAPPROVED HOMEOPATHIC-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 57556-006 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
57556-006
Proprietary Name:
Homeopathic Calm Drops
Non-Proprietary Name: [1]
Arsenic Trioxide 30c, Matricaria Chamomilla12x, Arabica Coffee Bean 30x, Potassium Carbonate30c, Strychnos Ignatii Seed30x, Lachesis Muta Venom12x, Phosphoric Acid 3x, Anemone Pulsatilla 12c, Valerian 30c, Aconitum Napellus 6x, Chloride Ion 12x, Strychnos Nux-vomica Seed 30c
Substance Name: [2]
Arsenic Trioxide; Matricaria Chamomilla; Arabica Coffee Bean; Potassium Carbonate; Strychnos Ignatii Seed; Lachesis Muta Venom; Phosphoric Acid; Pulsatilla Vulgaris Whole; Valerian; Aconitum Napellus Whole; Sodium Chloride; 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:
69c35bc2-b9a0-4bb4-a56d-0e2d1c3f7958
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

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 57556-006?

The NDC code 57556-006 is assigned by the FDA to the product Homeopathic Calm Drops. It is commonly known by its generic name, arsenic trioxide 30c, matricaria chamomilla12x, arabica coffee bean 30x, potassium carbonate30c, strychnos ignatii seed30x, lachesis muta venom12x, phosphoric acid 3x, anemone pulsatilla 12c, valerian 30c, aconitum napellus 6x, chloride ion 12x, strychnos nux-vomica seed 30c. 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: 57556-006-01. 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?

For temporary relief of occasional anxiety, tension and irritability. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.Aconitum nap 6X, Arsenicum alb 30C, Calcarea carb 30X, Chamomilla 12X, Ignatia 30X, Kali carb 30C, Lachesis 12X, Natrum mur 12X, Nux vom 30C, Phosphoricum ac 3X, Pulsatilla 12C, Sepia 30C.Equal volumes of each ingredient.

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:

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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".