Home NDC 43857-0640 Apizelen
Product NDC 43857-0640
11-digit product format 438570640
Labeler code 43857
Product ID 43857-0640_0dcdec86-b567-439d-8009-e3db4bfec2c0
Type HUMAN OTC DRUG
Nonproprietary name Germanium Metallicum, Alfalfa, Aralia Quinquefolia, Avena Sativa, Beta Vulgaris, Calendula Officinalis, Chelidonium Majus, Echinacea (Angustifolia), Natrum Muriaticum, Paloondo, Phytolacca Decandra, Taraxacum Officinale, Trifolium Pratense, Urtica Dioica, Viscum Album, Cobalt Acetate, Cobalt Gluconate, Copper Gluconate, Cuprum Aceticum, Glutathione, Magnesium Gluconicum Dihydricum, Ganoderma Lucidum, Ubidecarenonum, Argentum Metallicum
Dosage form LIQUID
Route ORAL
Labeler BioActive Nutritional, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2024-05-15
Substance AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; BETA VULGARIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS WHOLE; COBALTOUS ACETATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; CUPRIC ACETATE; ECHINACEA ANGUSTIFOLIA WHOLE; GERMANIUM; GLUTATHIONE; LARREA TRIDENTATA LEAF; MAGNESIUM GLUCONATE; MEDICAGO SATIVA WHOLE; PHYTOLACCA AMERICANA ROOT; REISHI; SILVER; SODIUM CHLORIDE; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; UBIDECARENONE; URTICA DIOICA WHOLE; VISCUM ALBUM FRUITING TOP
Active strength 2; 2; 2; 2; 2; 3; 3; 3; 3; 2; 15; 3; 2; 3; 2; 2; 5; 8; 2; 2; 2; 5; 2; 2 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes Calculi Dissolution Agent [EPC], 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 Apizelen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GERMANIUM 2 [hp_C]/mL MEDICAGO SATIVA WHOLE 2 [hp_C]/mL AMERICAN GINSENG 2 [hp_C]/mL AVENA SATIVA FLOWERING TOP 2 [hp_C]/mL BETA VULGARIS WHOLE 2 [hp_C]/mL CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_C]/mL CHELIDONIUM MAJUS WHOLE 3 [hp_C]/mL ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_C]/mL SODIUM CHLORIDE 3 [hp_C]/mL LARREA TRIDENTATA LEAF 2 [hp_C]/mL PHYTOLACCA AMERICANA ROOT 15 [hp_X]/mL TARAXACUM OFFICINALE 3 [hp_C]/mL TRIFOLIUM PRATENSE FLOWER 2 [hp_C]/mL URTICA DIOICA WHOLE 3 [hp_C]/mL VISCUM ALBUM FRUITING TOP 2 [hp_C]/mL COBALTOUS ACETATE 2 [hp_C]/mL COBALTOUS GLUCONATE 5 [hp_C]/mL COPPER GLUCONATE 8 [hp_C]/mL CUPRIC ACETATE 2 [hp_C]/mL GLUTATHIONE 2 [hp_C]/mL MAGNESIUM GLUCONATE 2 [hp_C]/mL REISHI 5 [hp_C]/mL UBIDECARENONE 2 [hp_C]/mL SILVER 2 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 24 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 43857-0640-1 Apizelen 30 mL in 1 BOTTLE, DROPPER LIQUID 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0640 APIZELEN (GERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.] 1 Current NDC, 1 package rows 20240517_471a7fab-1ef1-4d13-a28e-75f9762a711a.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 Apizelen GERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUM BioActive Nutritional, Inc. 471a7fab-1ef1-4d13-a28e-75f9762a711a 2026-06-08 Warnings Exact identifier ndc (product): 43857-0640
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43857-0640-1 43857064001 30 mL in 1 BOTTLE, DROPPER (43857-0640-1) 30 ml 2024-05-15 No No Current