{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-05-12", "results": { "skip": 0, "limit": 1, "total": 13 } }, "results": [ { "spl_product_data_elements": [ "Allergies Apis mellifica, Echinacea, Hydrastis canadensis, Taraxacum officinale, Aconitum napellus, Aethusa cynapium, Agaricus muscarius, Aletris farinosa, Alfalfa, Allium cepa, Allium sativum, Ambrosia artemisiaefolia, Arsenicum album, Artemisia vulgaris, Arundo mauritanica, Avena sativa, Belladonna, Bellis perrenis, Bovista, Bromium, Bryonia, Caffeinum, Calcarea carbonica, Calluna vulgaris, flos, Capsicum annuum, Cat hair, Chamomilla, Chelidonium majus, Chenopodium anthelminticum, Cinnamomum ULMUS RUBRA BARK ULMUS RUBRA BARK EGG SHELL, COOKED EGG SHELL, COOKED SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED SAMBUCUS NIGRA FLOWERING TOP SAMBUCUS NIGRA FLOWERING TOP SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT LYCOPUS VIRGINICUS LYCOPUS VIRGINICUS LACTOSE, UNSPECIFIED FORM ANHYDROUS LACTOSE CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM TRILLIUM ERECTUM ROOT TRILLIUM ERECTUM ROOT ASCORBIC ACID ASCORBIC ACID BLACK MUSTARD SEED BLACK MUSTARD SEED DATURA STRAMONIUM DATURA STRAMONIUM TOBACCO LEAF TOBACCO LEAF ALLYLTHIOUREA ALLYLTHIOUREA URTICA URENS URTICA URENS ELYMUS REPENS ROOT ELYMUS REPENS ROOT USTILAGO MAYDIS USTILAGO MAYDIS WYETHIA HELENIOIDES ROOT WYETHIA HELENIOIDES ROOT XEROPHYLLUM ASPHODELOIDES XEROPHYLLUM ASPHODELOIDES WATER APIS MELLIFERA APIS MELLIFERA TARAXACUM OFFICINALE TARAXACUM OFFICINALE ACONITUM NAPELLUS ACONITUM NAPELLUS AETHUSA CYNAPIUM AETHUSA CYNAPIUM ALCOHOL AMANITA MUSCARIA FRUITING BODY AMANITA MUSCARIA FRUITING BODY ALETRIS FARINOSA ROOT ALETRIS FARINOSA ROOT ALFALFA ALFALFA ONION ONION GARLIC GARLIC AMBROSIA ARTEMISIIFOLIA AMBROSIA ARTEMISIIFOLIA ARSENIC TRIOXIDE ARSENIC CATION (3+) ARTEMISIA VULGARIS ROOT ARTEMISIA VULGARIS ROOT ARUNDO PLINIANA ROOT ARUNDO PLINIANA ROOT AVENA SATIVA FLOWERING TOP AVENA SATIVA FLOWERING TOP ATROPA BELLADONNA ATROPA BELLADONNA BELLIS PERENNIS BELLIS PERENNIS LYCOPERDON UTRIFORME FRUITING BODY LYCOPERDON UTRIFORME FRUITING BODY BROMINE BROMINE BRYONIA ALBA ROOT BRYONIA ALBA ROOT CAFFEINE CAFFEINE OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE CALLUNA VULGARIS FLOWERING TOP CALLUNA VULGARIS FLOWERING TOP CAPSICUM CAPSICUM FELIS CATUS HAIR FELIS CATUS HAIR MATRICARIA CHAMOMILLA MATRICARIA CHAMOMILLA CHELIDONIUM MAJUS CHELIDONIUM MAJUS DYSPHANIA AMBROSIOIDES DYSPHANIA AMBROSIOIDES CINNAMON CINNAMON HELIANTHEMUM CANADENSE HELIANTHEMUM CANADENSE PROTORTONIA CACTI PROTORTONIA CACTI CYNARA SCOLYMUS LEAF CYNARA SCOLYMUS LEAF CANIS LUPUS FAMILIARIS HAIR CANIS LUPUS FAMILIARIS HAIR DROSERA ANGLICA DROSERA ANGLICA SOLANUM DULCAMARA TOP SOLANUM DULCAMARA TOP EUPHRASIA STRICTA EUPHRASIA STRICTA FAGOPYRUM ESCULENTUM FAGOPYRUM ESCULENTUM FAGUS SYLVATICA NUT FAGUS SYLVATICA NUT ALPINE STRAWBERRY ALPINE STRAWBERRY FRAXINUS AMERICANA BARK FRAXINUS AMERICANA BARK GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT HISTAMINE DIHYDROCHLORIDE HISTAMINE HOUSE DUST HOUSE DUST HYOSCYAMUS NIGER HYOSCYAMUS NIGER ABRUS PRECATORIUS SEED ABRUS PRECATORIUS SEED JUGLANS REGIA LEAF JUGLANS REGIA LEAF POTASSIUM IODIDE IODIDE ION COW MILK COW MILK RHODODENDRON TOMENTOSUM LEAFY TWIG RHODODENDRON TOMENTOSUM LEAFY TWIG LILIUM LANCIFOLIUM WHOLE FLOWERING LILIUM LANCIFOLIUM WHOLE FLOWERING ONOSMODIUM VIRGINIANUM ONOSMODIUM VIRGINIANUM PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT YUCCA FILAMENTOSA YUCCA FILAMENTOSA SACCHARIN SACCHARIN ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED GOLDENSEAL GOLDENSEAL TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SALIX NIGRA BARK SALIX NIGRA BARK SULFUR SULFUR POPULUS BALSAMIFERA LEAF BUD POPULUS BALSAMIFERA LEAF BUD QUERCUS ROBUR NUT QUERCUS ROBUR NUT MENTHA PIPERITA MENTHA PIPERITA NUTMEG NUTMEG SOLANUM LYCOPERSICUM SOLANUM LYCOPERSICUM ANACARDIUM OCCIDENTALE FRUIT ANACARDIUM OCCIDENTALE FRUIT PTELEA TRIFOLIATA BARK PTELEA TRIFOLIATA BARK LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE ANEMONE PULSATILLA ANEMONE PULSATILLA ROSA X DAMASCENA FLOWERING TOP ROSA X DAMASCENA FLOWERING TOP ASTACUS ASTACUS ASTACUS ASTACUS GLYCYRRHIZA GLABRA GLYCYRRHIZA GLABRA JUNIPERUS VIRGINIANA TWIG JUNIPERUS VIRGINIANA TWIG SUCROSE SUCROSE SODIUM NITRATE NITRATE ION SOLANUM NIGRUM WHOLE SOLANUM NIGRUM WHOLE SOLANUM TUBEROSUM SOLANUM TUBEROSUM PARTHENIUM HYSTEROPHORUS PARTHENIUM HYSTEROPHORUS GINGER GINGER SODIUM CHLORIDE SODIUM CATION POPULUS TREMULOIDES LEAF POPULUS TREMULOIDES LEAF CORN SILK CORN SILK SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset." ], "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose." ], "active_ingredient": [ "OTC - ACTIVE INGREDIENT SECTION Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Aconitum napellus 15x, Aethusa cynapium 15x, Agaricus muscarius 15x, Aletris farinosa 15x, Alfalfa 15x, Allium cepa 15x, Allium sativum 15x, Ambrosia artemisiaefolia 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Avena sativa 15x, Belladonna 15x, Bellis perrenis 15x, Bovista 15x, Bromium 15x, Bryonia 15x, Caffeinum 15x, Calcarea carbonica 15x, Calluna vulgaris, flos 15x, Capsicum annuum 15x, Cat hair 15x, Chamomilla 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cinnamomum 15x, Cistus canadensis 15x, Coccus cacti 15x, Cynara scolymus 15x, Dog hair 15x, Drosera 15x, Dulcamara 15x, Euphrasia officinalis 15x, Fagopyrum esculentum 15x, Fagus sylvatica 15x, Fragaria vesca 15x, Fraxinis americana 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, House dust 15x, Hyoscyamus niger 15x, Jequirity 15x, Juglans regia 15x, Kali iodatum 15x, Lac vaccinum 15x, Ledum palustre 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Lycopus virginicus 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Onosmodium virginianum 15x, Ova tosta 15x, Phytolacca decandra 15x, Populus candicans 15x, Populus tremuloides 15x, Ptelea trifoliata 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rhus toxicodendron 15x, Rosa damascena 15x, Sabadilla 15x, Saccharinum 15x, Saccharum lactis 15x, Salix nigra 15x, Sambucus nigra 15x, Sanguinaria canadensis 15x, Secale cornutum 15x, Stramonium 15x, Sulphur 15x, Tabacum 15x, Thiosinaminum 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Juniperus virginiana 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Parthenium 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x, Ulmus fulva 16x, Yucca filamentosa 16x." ], "purpose": [ "OTC - PURPOSE SECTION Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset." ], "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%." ], "questions": [ "QUESTIONS SECTION newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013" ], "warnings": [ "WARNINGS SECTION WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use." ], "pregnancy_or_breast_feeding": [ "OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding , ask a doctor before use." ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children." ], "package_label_principal_display_panel": [ "PACKAGE LABEL package label" ], "set_id": "017f0210-195d-11d7-e063-6294a90aa750", "id": "017f025d-6fca-ec96-e063-6394a90a4e44", "effective_time": "20230727", "version": "1", "openfda": { "brand_name": [ "Allergies" ], "generic_name": [ "APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM" ], "manufacturer_name": [ "Newton Laboratories, Inc." ], "product_ndc": [ "55714-2584" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ABRUS PRECATORIUS SEED", "ACONITUM NAPELLUS", "AETHUSA CYNAPIUM", "ALETRIS FARINOSA ROOT", "ALFALFA", "ALLYLTHIOUREA", "ALPINE STRAWBERRY", "AMANITA MUSCARIA FRUITING BODY", "AMBROSIA ARTEMISIIFOLIA", "ANACARDIUM OCCIDENTALE FRUIT", "ANEMONE PULSATILLA", "APIS MELLIFERA", "ARSENIC TRIOXIDE", "ARTEMISIA VULGARIS ROOT", "ARUNDO PLINIANA ROOT", "ASCORBIC ACID", "ASTACUS ASTACUS", "ATROPA BELLADONNA", "AVENA SATIVA FLOWERING TOP", "BELLIS PERENNIS", "BLACK MUSTARD SEED", "BROMINE", "BRYONIA ALBA ROOT", "CAFFEINE", "CALLUNA VULGARIS FLOWERING TOP", "CANIS LUPUS FAMILIARIS HAIR", "CAPSICUM", "CHELIDONIUM MAJUS", "CINNAMON", "CLAVICEPS PURPUREA SCLEROTIUM", "CORN SILK", "COW MILK", "CYNARA SCOLYMUS LEAF", "DATURA STRAMONIUM", "DROSERA ANGLICA", "DYSPHANIA AMBROSIOIDES", "ECHINACEA, UNSPECIFIED", "EGG SHELL, COOKED", "ELYMUS REPENS ROOT", "EUPHRASIA STRICTA", "FAGOPYRUM ESCULENTUM", "FAGUS SYLVATICA NUT", "FELIS CATUS HAIR", "FRAXINUS AMERICANA BARK", "GARLIC", "GELSEMIUM SEMPERVIRENS ROOT", "GINGER", "GLYCYRRHIZA GLABRA", "GOLDENSEAL", "HELIANTHEMUM CANADENSE", "HISTAMINE DIHYDROCHLORIDE", "HOUSE DUST", "HYOSCYAMUS NIGER", "JUGLANS REGIA LEAF", "JUNIPERUS VIRGINIANA TWIG", "LACTOSE, UNSPECIFIED FORM", "LILIUM LANCIFOLIUM WHOLE FLOWERING", "LYCOPERDON UTRIFORME FRUITING BODY", "LYCOPODIUM CLAVATUM SPORE", "LYCOPUS VIRGINICUS", "MATRICARIA CHAMOMILLA", "MENTHA PIPERITA", "NUTMEG", "ONION", "ONOSMODIUM VIRGINIANUM", "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "PARTHENIUM HYSTEROPHORUS", "PHYTOLACCA AMERICANA ROOT", "POPULUS BALSAMIFERA LEAF BUD", "POPULUS TREMULOIDES LEAF", "POTASSIUM IODIDE", "PROTORTONIA CACTI", "PTELEA TRIFOLIATA BARK", "QUERCUS ROBUR NUT", "RHODODENDRON TOMENTOSUM LEAFY TWIG", "ROSA X DAMASCENA FLOWERING TOP", "SACCHARIN", "SACCHAROMYCES CEREVISIAE", "SALIX NIGRA BARK", "SAMBUCUS NIGRA FLOWERING TOP", "SANGUINARIA CANADENSIS ROOT", "SCHOENOCAULON OFFICINALE SEED", "SODIUM CHLORIDE", "SODIUM NITRATE", "SOLANUM DULCAMARA TOP", "SOLANUM LYCOPERSICUM", "SOLANUM NIGRUM WHOLE", "SOLANUM TUBEROSUM", "SUCROSE", "SULFUR", "TARAXACUM OFFICINALE", "TOBACCO LEAF", "TOXICODENDRON PUBESCENS LEAF", "TRILLIUM ERECTUM ROOT", "ULMUS RUBRA BARK", "URTICA URENS", "USTILAGO MAYDIS", "WYETHIA HELENIOIDES ROOT", "XEROPHYLLUM ASPHODELOIDES", "YUCCA FILAMENTOSA" ], "spl_id": [ "017f025d-6fca-ec96-e063-6394a90a4e44" ], "spl_set_id": [ "017f0210-195d-11d7-e063-6294a90aa750" ], "package_ndc": [ "55714-2584-1" ], "is_original_packager": [ true ], "nui": [ "N0000185021", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0002274", "N0000193618", "M0001797", "N0000175739", "N0000175729", "N0000175790", "M0023046", "N0000185363", "M0370530", "N0000185375", "N0000185371", "M0006342", "M0016962", "M0022575", "M0008672", "M0013890", "N0000185003", "M0576325", "M0515971", "N0000185374", "M0006896", "M0516536", "N0000185372", "M0008890" ], "pharm_class_epc": [ "Standardized Insect Venom Allergenic Extract [EPC]", "Vitamin C [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]", "Non-Standardized Animal Hair Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Standardized Animal Hair Allergenic Extract [EPC]", "Non-Standardized House Dust Allergenic Extract [EPC]", "Non-Standardized Fungal Allergenic Extract [EPC]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]", "Central Nervous System Stimulation [PE]" ], "pharm_class_cs": [ "Allergens [CS]", "Bee Venoms [CS]", "Ascorbic Acid [CS]", "Xanthines [CS]", "Animal Fur [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Vegetable Proteins [CS]", "Food Additives [CS]", "Milk Proteins [CS]", "Dander [CS]", "Salivary Proteins and Peptides [CS]", "House Dust [CS]", "Seed Storage Proteins [CS]", "Fungal Proteins [CS]" ], "unii": [ "3OM8I6L7CD", "U0NQ8555JD", "M6936L953C", "O021JGR97X", "DJO934BRBD", "706IDJ14B7", "CG6IX3GCMU", "DIF093I037", "9W34L2CQ9A", "4A10JR4E7E", "I76KB35JEV", "7S82P3R43Z", "S7V92P67HO", "32MP823R8S", "ZXE7LB03WC", "PQ6CK8PD0R", "V0551986XQ", "WQZ3G9PF0H", "MA9CQJ3F7F", "2HU33I03UY", "8LTY55LQ8D", "SBV4XY874G", "T7J046YI2B", "3G6A5W338E", "D9PC510CQV", "05S7L91ZTR", "00UK7646FG", "7E889U5RNN", "5S29HWU6QB", "01G9XEA93N", "7D3VB244UX", "917J3173FT", "B71UA545DE", "G6W4F0V8Z3", "J61BY05EGY", "4H5RSU087I", "4N9P6CC1DX", "24HBF856C8", "3IXW0F6P8W", "C9642I91WL", "B10M69172N", "I57ERU2601", "1564HD0N96", "0B24UR1O1S", "V1V998DC17", "639KR60Q1Q", "C5529G5JPQ", "2788Z9758H", "ZW3Z11D0JV", "46G3W789Q3", "3POA0Q644U", "EYO007VX98", "4WRK2153H3", "85HKB87105", "532BCG080L", "J2B2A4N98G", "X67Z2963PI", "K2A74U428F", "C88X29Y479", "TWH5125Q6F", "G0R4UBI2ZZ", "79M2M2UDA9", "AEE24M3MQ9", "492225Q21H", "604NK4250S", "2E32821G6I", "151F45R21P", "11E6VI8VEG", "9CQ6C00G3C", "7IIH57D9E0", "1C4QK22F9J", "LZB7TFX1LT", "5KQR6FTT0D", "Q7MU1F4GLY", "877L01IZ0P", "21W82Q764G", "FST467XS7D", "978D8U419H", "QU52J3A5B3", "CT03BSA18U", "N9288CD508", "6NAF1689IO", "451W47IQ8X", "8M4L3H2ZVZ", "KPS1B1162N", "0243Q4990L", "0FMD6WV47M", "2A8I57T4MX", "C151H8M554", "70FD1KFU70", "39981FM375", "6YR2608RSU", "6IO182RP7A", "AHW6F0T2X0", "91QY4PXU8Q", "IHN2NQ5OF9", "4K7Z7K7SWG", "J10PD1AQ0N", "9I4XB1GP2B", "T6VR38UJ9I" ] } } ] }