44911-0411 NDC - COLOSTAT (RHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICA)

Drug Information

Product NDC: 44911-0411

Proprietary Name: Colostat

Non Proprietary Name: Rhamnus Purshiana, Spigelia Anthelmia, Taraxacum Officinale, Cajuputum, Hydrastis Canadensis, Alumina, Cina, Cinchona Officinalis, Lycopodium Clavatum, Magnesia Phosphorica, Mandragora Officinarum, Nux Vomica

Active Ingredient(s):
  • 12 [hp_X]/mL ALUMINUM OXIDE;
  • 12 [hp_X]/mL ARTEMISIA CINA PRE-FLOWERING TOP;
  • 6 [hp_X]/mL CAJUPUT OIL;
  • 12 [hp_X]/mL CINCHONA OFFICINALIS BARK;
  • 3 [hp_X]/mL FRANGULA PURSHIANA BARK;
  • 6 [hp_X]/mL GOLDENSEAL;
  • 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE;
  • 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE;
  • 12 [hp_X]/mL MANDRAGORA OFFICINARUM ROOT;
  • 3 [hp_X]/mL SPIGELIA ANTHELMIA;
  • 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED;
  • 3 [hp_X]/mL TARAXACUM OFFICINALE


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Allergens [CS];
  • Calculi Dissolution Agent [EPC];
  • Cell-mediated Immunity [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Increased Large Intestinal Motility [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE];
  • Magnesium Ion Exchange Activity [MoA];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC];
  • Plant Proteins [CS];
  • Seed Storage Proteins [CS];
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Labeler Name: Energique, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:12/30/2016

Package Information

No. Package Code Package Description Billing Unit
144911-0411-130 mL in 1 BOTTLE, DROPPER (44911-0411-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC44911-0411The 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 NAMEColostatThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMERhamnus Purshiana, Spigelia Anthelmia, Taraxacum Officinale, Cajuputum, Hydrastis Canadensis, Alumina, Cina, Cinchona Officinalis, Lycopodium Clavatum, Magnesia Phosphorica, Mandragora Officinarum, Nux VomicaThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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 DATE12/30/2016This 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 NAMEEnergique, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALUMINUM OXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; CAJUPUT OIL; CINCHONA OFFICINALIS BARK; FRANGULA PURSHIANA BARK; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANDRAGORA OFFICINARUM ROOT; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALEAn 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 STRENGTH12; 12; 6; 12; 3; 6; 12; 12; 12; 3; 12; 3 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

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