64578-0085 NDC - HEPATIC-TONE (CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALE)

Drug Information

  • Product NDC: 64578-0085
  • Proprietary Name: Hepatic-Tone
  • Non Proprietary Name: Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Citricum Acidum, Cysteinum, Hepar Suis, Leptandra Virginica, Magnesia Muriatica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Quassia (Amara), Taraxacum Officinale
  • Active Ingredient(s): 8 [hp_X]/mL ANHYDROUS CITRIC ACID; 12 [hp_X]/mL CEANOTHUS AMERICANUS LEAF; 4 [hp_X]/mL CHELIDONIUM MAJUS; 8 [hp_X]/mL CHIONANTHUS VIRGINICUS BARK; 8 [hp_X]/mL CYSTEINE; 8 [hp_X]/mL MAGNESIUM CHLORIDE; 4 [hp_X]/mL MILK THISTLE; 12 [hp_X]/mL PHOSPHORUS; 9 [hp_X]/mL PORK LIVER; 4 [hp_X]/mL QUASSIA AMARA WOOD; 12 [hp_X]/mL SODIUM SULFATE; 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED; 4 [hp_X]/mL TARAXACUM OFFICINALE; 12 [hp_X]/mL VERONICASTRUM VIRGINICUM ROOT
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Acidifying Activity [MoA]; Allergens [CS]; Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Calculi Dissolution Agent [EPC]; Cell-mediated Immunity [PE]; Decreased Coagulation Factor Activity [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

Field Name Field Value
Labeler Name: Energetix Corp
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/29/2014

Package Information

No. Package Code Package Description Billing Unit
164578-0085-159.1 mL in 1 BOTTLE, DROPPER (64578-0085-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC64578-0085The 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 NAMEHepatic-ToneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECarduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Citricum Acidum, Cysteinum, Hepar Suis, Leptandra Virginica, Magnesia Muriatica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Quassia (Amara), Taraxacum OfficinaleThe 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 DATE5/29/2014This 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 NAMEEnergetix CorpName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANHYDROUS CITRIC ACID; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CYSTEINE; MAGNESIUM CHLORIDE; MILK THISTLE; PHOSPHORUS; PORK LIVER; QUASSIA AMARA WOOD; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM 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 STRENGTH8; 12; 4; 8; 8; 8; 4; 12; 9; 4; 12; 12; 4; 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 
PHARM CLASSESAcidifying Activity [MoA], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [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: 7/4/2025

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