Home NDC 43857-0458 Gastrotone
Product NDC 43857-0458
11-digit product format 438570458
Labeler code 43857
Product ID 43857-0458_eaf2ae33-b4c6-473b-97bd-0f4a7ba4602b
Type HUMAN OTC DRUG
Nonproprietary name Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Arsenicum Album, Magnesia Phosphorica, Pulsatilla (Vulgaris)
Dosage form LIQUID
Route ORAL
Labeler BioActive Nutritional, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-09-05
Substance ARSENIC TRIOXIDE; CAPSICUM; COMFREY ROOT; FENNEL SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS WHOLE; SILVER NITRATE
Active strength 12; 3; 6; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [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 Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vegetable Proteins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Gastrotone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSICUM 12 [hp_X]/mL FENNEL SEED 3 [hp_X]/mL COMFREY ROOT 6 [hp_X]/mL SILVER NITRATE 3 [hp_X]/mL ARSENIC TRIOXIDE 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/mL PULSATILLA VULGARIS WHOLE 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 7 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 43857-0458-1 Gastrotone 30 mL in 1 BOTTLE, DROPPER LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0458 GASTROTONE (CAPSICUM ANNUUM, FOENICULUM VULGARE, SYMPHYTUM OFFICINALE, ARGENTUM NITRICUM, ARSENICUM ALBUM, MAGNESIA PHOSPHORICA, PULSATILLA (VULGARIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20170906_1ba810f2-ee90-400c-81d7-d066c5eebe59.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 Gastrotone CAPSICUM ANNUUM, FOENICULUM VULGARE, SYMPHYTUM OFFICINALE, ARGENTUM NITRICUM, ARSENICUM ALBUM, MAGNESIA PHOSPHORICA, PULSATILLA (VULGARIS) BioActive Nutritional, Inc. 1ba810f2-ee90-400c-81d7-d066c5eebe59 2026-05-07 Warnings Exact identifier ndc (product): 43857-0458
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43857-0458-1 43857045801 30 mL in 1 BOTTLE, DROPPER (43857-0458-1) 30 ml 2017-09-05 0000-00-00 No No Current