NDC 57556-006 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

NDC Product Code 57556-006

NDC CODE: 57556-006

Proprietary Name: Homeopathic Calm Drops What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary 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 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).
  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 57556 - Historical Remedies Llp.

NDC 57556-006-01

Package Description: 30 LOZENGE in 1 BOX

NDC Product Information

Homeopathic Calm Drops with NDC 57556-006 is a a human over the counter drug product labeled by Historical Remedies Llp.. The generic name of Homeopathic Calm Drops is 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. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Historical Remedies Llp.

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.

Product Type: Human Otc Drug 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.

Homeopathic Calm Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ARSENIC TRIOXIDE 30 [hp_C]/1
  • MATRICARIA CHAMOMILLA 12 [hp_X]/1
  • ARABICA COFFEE BEAN 30 [hp_X]/1
  • POTASSIUM CARBONATE 30 [hp_C]/1
  • STRYCHNOS IGNATII SEED 30 [hp_X]/1
  • LACHESIS MUTA VENOM 12 [hp_X]/1
  • PHOSPHORIC ACID 3 [hp_X]/1
  • PULSATILLA VULGARIS WHOLE 12 [hp_C]/1
  • VALERIAN 30 [hp_C]/1
  • ACONITUM NAPELLUS WHOLE 6 [hp_X]/1
  • SODIUM CHLORIDE 12 [hp_X]/1
  • STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ACHLYS TRIPHYLLA WHOLE (UNII: 91THU5EJ2I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Historical Remedies Llp.
Labeler Code: 57556
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 05-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Homeopathic Calm Drops Product Label Images

Homeopathic Calm Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications

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.

Directions

Adults and children over 8: Dissolve one Calm Drops lozenge in mouth. Repeat every half hour as needed.

Warnings

If symptoms persist more than 7 days or worsen, consult a physician. Keep out of children's reach. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breast-feeding, ask a doctor before use. Do not use if shrink wrap is broken or missing.

Active Ingredients

Aconitum nap 6X, Arsenicum alb 30C, Calcarea carb 30X, Chamomilla 12X, lgnatia 30X, Kali carb 30C, Lachesis 12X, Natrum mur 12X, Nux vom 30C, Phosphoricum ac 3X, Pulsatilla 12C, Sepia 30C.

Inactive Ingredients

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Organic Vanilla Flavor.4 calories per lozenge. 1 gram sugar per lozenge. No gluten added.

* Please review the disclaimer below.