43857-0553 NDC - COLOTOX (ALFALFA, BERBERIS VULGARIS, RHAMNUS PURSHIANA, RHEUM (PALMATUM), TARAXACUM OFFICINALE, HEPAR BOVINE, SMALL INTESTINE (SUIS), ARANEA DIADEMA, CARBO ANIMALIS, CARBO VEGETABILIS, CINA, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, SELENIUM METALLICUM, SPIGELIA ANTHELMIA, VERATRUM ALBUM, BILIRUBIN, CREATINE, CREATININE, INDOLUM, SKATOLUM, PROTEUS (MIRABILIS), MORGAN GAERTNER)

Drug Information

  • Product NDC: 43857-0553
  • Proprietary Name: Colotox
  • Non Proprietary Name: Alfalfa, Berberis Vulgaris, Rhamnus Purshiana, Rheum (Palmatum), Taraxacum Officinale, Hepar Bovine, Small Intestine (Suis), Aranea Diadema, Carbo Animalis, Carbo Vegetabilis, CINA, Mandragora Officinarum, Mercurius Solubilis, Selenium Metallicum, Spigelia Anthelmia, Veratrum Album, Bilirubin, Creatine, Creatinine, Indolum, Skatolum, Proteus (Mirabilis), Morgan Gaertner
  • Active Ingredient(s): 12 [hp_X]/mL ACTIVATED CHARCOAL; 12 [hp_X]/mL ARANEUS DIADEMATUS; 12 [hp_X]/mL ARTEMISIA CINA PRE-FLOWERING TOP; 8 [hp_X]/mL BEEF LIVER; 3 [hp_X]/mL BERBERIS VULGARIS ROOT BARK; 15 [hp_X]/mL BILIRUBIN; 12 [hp_X]/mL CARBO ANIMALIS; 15 [hp_X]/mL CREATINE; 15 [hp_X]/mL CREATININE; 3 [hp_X]/mL FRANGULA PURSHIANA BARK; 15 [hp_X]/mL INDOLE; 12 [hp_X]/mL MANDRAGORA OFFICINARUM ROOT; 3 [hp_X]/mL MEDICAGO SATIVA WHOLE; 12 [hp_X]/mL MERCURIUS SOLUBILIS; 20 [hp_X]/mL PROTEUS MIRABILIS; 3 [hp_X]/mL RHEUM PALMATUM ROOT; 12 [hp_C]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; 12 [hp_X]/mL SELENIUM; 15 [hp_X]/mL SKATOLE; 12 [hp_X]/mL SPIGELIA ANTHELMIA WHOLE; 8 [hp_X]/mL SUS SCROFA INTESTINAL MUCOSA; 3 [hp_X]/mL TARAXACUM OFFICINALE; 12 [hp_X]/mL VERATRUM ALBUM ROOT
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Meat Proteins [EXT]; Non-Standardized Food Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
Labeler Name: BioActive Nutritional, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/23/2020
End Marketing Date:10/17/2029

Package Information

No. Package Code Package Description Billing Unit
143857-0553-130 mL in 1 BOTTLE, DROPPER (43857-0553-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43857-0553The 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 NAMEColotoxThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAlfalfa, Berberis Vulgaris, Rhamnus Purshiana, Rheum (Palmatum), Taraxacum Officinale, Hepar Bovine, Small Intestine (Suis), Aranea Diadema, Carbo Animalis, Carbo Vegetabilis, CINA, Mandragora Officinarum, Mercurius Solubilis, Selenium Metallicum, Spigelia Anthelmia, Veratrum Album, Bilirubin, Creatine, Creatinine, Indolum, Skatolum, Proteus (Mirabilis), Morgan GaertnerThe 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 DATE3/23/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/17/2029This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 NAMEBioActive Nutritional, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACTIVATED CHARCOAL; ARANEUS DIADEMATUS; ARTEMISIA CINA PRE-FLOWERING TOP; BEEF LIVER; BERBERIS VULGARIS ROOT BARK; BILIRUBIN; CARBO ANIMALIS; CREATINE; CREATININE; FRANGULA PURSHIANA BARK; INDOLE; MANDRAGORA OFFICINARUM ROOT; MEDICAGO SATIVA WHOLE; MERCURIUS SOLUBILIS; PROTEUS MIRABILIS; RHEUM PALMATUM ROOT; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENIUM; SKATOLE; SPIGELIA ANTHELMIA WHOLE; SUS SCROFA INTESTINAL MUCOSA; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOTAn 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; 12; 8; 3; 15; 12; 15; 15; 3; 15; 12; 3; 12; 20; 3; 12; 12; 15; 12; 8; 3; 12 
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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC] 

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This page was last updated on: 12/6/2025

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