Home NDC 70719-0003 Heilen
Product NDC 70719-0003
11-digit product format 707190003
Labeler code 70719
Product ID 70719-0003_a5b8f01b-807d-4afe-9392-abd145e524e3
Type HUMAN OTC DRUG
Nonproprietary name Galium Aparine, Agnus Castus, Apis Mellifica, Capsicum Annuum, Chelidonium Majus, Taraxacum Officinale, Urtica Dioica, Xanthoxylum Fraxineum, Fucus Vesiculosus, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum, Sarsaparilla (smilax Regelii), Ubidecarenonum, Calcarea Carbonica, Graphites, Lycopodium Clavatum, Anacardium Orientale, Colchicum Autumnale, Nux Vomica, Phytolacca Decandra, Pulsatilla (Pratensis), Histaminum Hydrochloricum
Dosage form LIQUID
Route ORAL
Labeler Heilen
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-01-21
Marketing end 2027-02-04
Substance GALIUM APARINE WHOLE; CHASTE TREE FRUIT; APIS MELLIFERA; CAPSICUM; CHELIDONIUM MAJUS WHOLE; TARAXACUM OFFICINALE; URTICA DIOICA WHOLE; ZANTHOXYLUM AMERICANUM BARK; FUCUS VESICULOSUS; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SMILAX ORNATA ROOT; UBIDECARENONE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; SEMECARPUS ANACARDIUM JUICE; COLCHICUM AUTUMNALE BULB; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PULSATILLA PRATENSIS WHOLE; HISTAMINE DIHYDROCHLORIDE
Active strength 3; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 200 [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [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], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vegetable 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 Heilen Active Ingredients# Ingredient, Strength table Ingredient Strength GALIUM APARINE WHOLE 3 [hp_X]/mL CHASTE TREE FRUIT 6 [hp_X]/mL APIS MELLIFERA 6 [hp_X]/mL CAPSICUM 6 [hp_X]/mL CHELIDONIUM MAJUS WHOLE 6 [hp_X]/mL TARAXACUM OFFICINALE 6 [hp_X]/mL URTICA DIOICA WHOLE 6 [hp_X]/mL ZANTHOXYLUM AMERICANUM BARK 6 [hp_X]/mL FUCUS VESICULOSUS 6 [hp_X]/mL DIBASIC POTASSIUM PHOSPHATE 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 12 [hp_X]/mL SMILAX ORNATA ROOT 12 [hp_X]/mL UBIDECARENONE 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL GRAPHITE 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL SEMECARPUS ANACARDIUM JUICE 30 [hp_C]/mL COLCHICUM AUTUMNALE BULB 30 [hp_C]/mL STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/mL PHYTOLACCA AMERICANA ROOT 30 [hp_C]/mL PULSATILLA PRATENSIS WHOLE 30 [hp_C]/mL HISTAMINE DIHYDROCHLORIDE 200 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 23 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 70719-0003-1 Heilen 30 mL in 1 BOTTLE, DROPPER LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70719-0003 HEILEN (GALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUM) LIQUID [HEILEN] 1 Current NDC, Legacy NDC, 1 package rows 20220123_ef3f66f9-47bc-4fce-8950-ed2319bc30d6.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 Heilen GALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUM Heilen ef3f66f9-47bc-4fce-8950-ed2319bc30d6 2026-01-12 Warnings Exact identifier ndc (product): 70719-0003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70719-0003-1 70719000301 30 mL in 1 BOTTLE, DROPPER (70719-0003-1) 30 ml 2022-01-21 2027-02-04 No No Current