Home NDC 43857-0619 STOMAPLEX
Product NDC 43857-0619
11-digit product format 438570619
Labeler code 43857
Product ID 43857-0619_290e3360-05d6-44e5-a876-a35c05b52cc3
Type HUMAN OTC DRUG
Nonproprietary name Carduus Marianus, Gentiana Lutea, Sambucus Nigra, Senna (Cassia Angustifolia), Stomach (Bovine), Arsenicum Album, Atropinum Sulphuricum, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus
Dosage form LIQUID
Route ORAL
Labeler BioActive Nutritional, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-11-01
Marketing end 2028-08-21
Substance SILYBUM MARIANUM SEED; GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; TRIPE; ARSENIC TRIOXIDE; ATROPINE SULFATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS
Active strength 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 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
Pharmacologic classes Allergens [CS], Anticholinergic [EPC], Cell-mediated Immunity [PE], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base STOMAPLEX Active Ingredients# Ingredient, Strength table Ingredient Strength SILYBUM MARIANUM SEED 3 [hp_X]/mL GENTIANA LUTEA ROOT 3 [hp_X]/mL SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]/mL SENNA LEAF 3 [hp_X]/mL TRIPE 8 [hp_X]/mL ARSENIC TRIOXIDE 12 [hp_X]/mL ATROPINE SULFATE 12 [hp_X]/mL ACTIVATED CHARCOAL 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL PHOSPHORUS 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43857-0619-1 STOMAPLEX 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 43857-0619 STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240913_e1b69e9b-ab47-49f4-bd91-89c935533d67.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 STOMAPLEX CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS BioActive Nutritional, Inc. e1b69e9b-ab47-49f4-bd91-89c935533d67 2024-09-11 Warnings Exact identifier ndc (product): 43857-0619
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43857-0619-1 43857061901 30 mL in 1 BOTTLE, DROPPER (43857-0619-1) 30 ml 2021-11-01 2028-08-21 No No Current