Home NDC 64578-0159 GB-Tone
Product NDC 64578-0159
11-digit product format 645780159
Labeler code 64578
Product ID 64578-0159_462b76d9-de5b-68ed-e063-6394a90aa23d
Type HUMAN OTC DRUG
Nonproprietary name Ammi vis, Atropinum sulphuricum, Boldo, Carduus mar, Chelidonium maj, Echinacea, Fel tauri, Hepar suis, Hydrastis, Leptandra, Mag phos, Nat phos, Podoph pelt, Taraxacum
Dosage form LIQUID
Route ORAL
Labeler Energetix Corporation
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-01-01
Substance ATROPINE SULFATE; BOS TAURUS BILE; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MILK THISTLE; PEUMUS BOLDUS LEAF; PODOPHYLLUM; PORK LIVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM ROOT; VISNAGA DAUCOIDES FRUIT
Active strength 12; 8; 12; 4; 5; 12; 4; 4; 12; 9; 6; 4; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL
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 VISNAGA DAUCOIDES FRUIT 12 [hp_X]/59.1mL ATROPINE SULFATE 8 [hp_X]/59.1mL PEUMUS BOLDUS LEAF 12 [hp_X]/59.1mL MILK THISTLE 4 [hp_X]/59.1mL CHELIDONIUM MAJUS 5 [hp_X]/59.1mL ECHINACEA, UNSPECIFIED 12 [hp_X]/59.1mL BOS TAURUS BILE 4 [hp_X]/59.1mL PORK LIVER 4 [hp_X]/59.1mL GOLDENSEAL 12 [hp_X]/59.1mL VERONICASTRUM VIRGINICUM ROOT 9 [hp_X]/59.1mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/59.1mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 4 [hp_X]/59.1mL PODOPHYLLUM 12 [hp_X]/59.1mL TARAXACUM OFFICINALE 12 [hp_X]/59.1mL
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 64578-0159-1 GB-Tone 59.1 mL in 1 BOTTLE LIQUID 59.1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64578-0159 GB-TONE (AMMI VIS, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS, LEPTANDRA, MAG PHOS, NAT PHOS, PODOPH PELT, TARAXACUM) LIQUID [ENERGETIX CORPORATION] 5 Current NDC, Legacy NDC, 1 package rows 20231229_1d857ae7-ad24-4f3b-8c33-f52851fa1ce6.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 VIS, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS, LEPTANDRA, MAG PHOS, NAT PHOS, PODOPH PELT, TARAXACUM Energetix Corporation 1d857ae7-ad24-4f3b-8c33-f52851fa1ce6 2025-12-17 Warnings Exact identifier ndc (product): 64578-0159
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64578-0159-1 64578015901 59.1 mL in 1 BOTTLE (64578-0159-1) 59.1 ml 2019-01-01 0000-00-00 No No Current