64578-0130 NDC - GB-TONE (AMMI VISNAGA, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS CANADENSIS, LEPTANDRA VIRGINICA, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, PODOPHYLLUM PELTATUM, TARAXACUM OFFICINALE)

Drug Information

  • Product NDC: 64578-0130
  • Proprietary Name: GB-Tone
  • Non Proprietary Name: Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale
  • Active Ingredient(s): 12 [hp_X]/mL AMMI VISNAGA FRUIT; 12 [hp_X]/mL ATROPINE SULFATE; 8 [hp_X]/mL BOS TAURUS BILE; 12 [hp_X]/mL CHELIDONIUM MAJUS; 4 [hp_X]/mL ECHINACEA ANGUSTIFOLIA; 5 [hp_X]/mL GOLDENSEAL; 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; 4 [hp_X]/mL MILK THISTLE; 4 [hp_X]/mL PEUMUS BOLDUS LEAF; 12 [hp_X]/mL PODOPHYLLUM; 9 [hp_X]/mL PORK LIVER; 6 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; 4 [hp_X]/mL TARAXACUM OFFICINALE; 12 [hp_X]/mL VERONICASTRUM VIRGINICUM ROOT
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Anticholinergic [EPC]; Calculi Dissolution Agent [EPC]; Cholinergic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; 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:7/14/2016

Package Information

No. Package Code Package Description Billing Unit
164578-0130-130 mL in 1 BOTTLE, DROPPER (64578-0130-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC64578-0130The 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 NAMEGB-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 NAMEAmmi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, 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 DATE7/14/2016This 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 NAMEEnergetix CorpName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAMMI VISNAGA FRUIT; ATROPINE SULFATE; BOS TAURUS BILE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MILK THISTLE; PEUMUS BOLDUS LEAF; PODOPHYLLUM; PORK LIVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; 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 STRENGTH12; 12; 8; 12; 4; 5; 12; 4; 4; 12; 9; 6; 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 CLASSESAnticholinergic [EPC], Calculi Dissolution Agent [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

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This page was last updated on: 11/21/2025

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