Home NDC 64578-0130 GB-Tone
Product NDC 64578-0130
11-digit product format 645780130
Labeler code 64578
Product ID 64578-0130_69332262-99a6-400f-9c7d-12cc674df851
Type HUMAN OTC DRUG
Nonproprietary 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
Dosage form LIQUID
Route ORAL
Labeler Energetix Corp
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2016-07-14
Substance AMMI 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 ROOT
Active strength 12; 12; 8; 12; 4; 5; 12; 4; 4; 12; 9; 6; 4; 12 [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
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base GB-Tone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMMI VISNAGA FRUIT 12 [hp_X]/mL ATROPINE SULFATE 12 [hp_X]/mL PEUMUS BOLDUS LEAF 8 [hp_X]/mL MILK THISTLE 12 [hp_X]/mL CHELIDONIUM MAJUS 4 [hp_X]/mL ECHINACEA ANGUSTIFOLIA 5 [hp_X]/mL BOS TAURUS BILE 12 [hp_X]/mL PORK LIVER 4 [hp_X]/mL GOLDENSEAL 4 [hp_X]/mL VERONICASTRUM VIRGINICUM ROOT 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 9 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]/mL PODOPHYLLUM 4 [hp_X]/mL TARAXACUM OFFICINALE 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 14 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64578-0130-1 GB-Tone 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64578-0130 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) LIQUID [ENERGETIX CORP] 4 Current NDC, Legacy NDC, 1 package rows 20180711_5620a1dc-b59c-4489-a548-20f3e488287f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Energetix Corp 5620a1dc-b59c-4489-a548-20f3e488287f 2018-07-11 Warnings Exact identifier ndc (product): 64578-0130
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64578-0130-1 64578013001 30 mL in 1 BOTTLE, DROPPER (64578-0130-1) 30 ml 2016-07-14 0000-00-00 No No Current