57556-006 NDC - 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)

Drug Information

Product NDC: 57556-006

Proprietary Name: Homeopathic Calm Drops

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

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


Administration Route(s): ORAL

Dosage Form(s): LOZENGE

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [CS];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Non-Standardized Food Allergenic Extract [EPC];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Plant Proteins [CS];
  • Plant Proteins [CS];
  • Seed Storage Proteins [CS];
  • Seed Storage Proteins [CS]

Labeler Information

Labeler Name: HISTORICAL REMEDIES LLP.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/1/2020

Package Information

No. Package Code Package Description Billing Unit
157556-006-0130 LOZENGE in 1 BOX (57556-006-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC57556-006The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEHomeopathic Calm DropsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEArsenic 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 30cThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELOZENGEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/1/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMEHISTORICAL REMEDIES LLP.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS WHOLE; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA; PHOSPHORIC ACID; POTASSIUM CARBONATE; PULSATILLA VULGARIS WHOLE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIANAn 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.
ACTIVE NUMERATOR STRENGTH6; 30; 30; 12; 12; 3; 30; 12; 12; 30; 30; 30 
ACTIVE INGRED UNIT[hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 
PHARM CLASSESAllergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 2/1/2023