{ "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. 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BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUS", "ACETICUM ACIDUM, ADRENALINUM, AMERICAN GINSENG, ARNICA MONTANA, BALSAMUM PERUVIANUM, BOS TAURUS PITUITARUM POSTERIUM, CHERRY PLUM FLOWER, CHININUM ARSENICOSUM, CINCHONA OFFICINALIS, CLEMATIS VITALBA FLOWER, DAMIANA, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE FLOWER, GLYCYRRHIZA GLABRA, IMPATIENS GLANDULIFERA FLOWER, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYRENEES STAR OF BETHLEHEM, ROCKROSE FLOWER, SELENIUM METALLICUM, THYROIDINUM" ], "manufacturer_name": [ "Apex Energetics Inc." ], "product_ndc": [ "63479-0205", "63479-0201", "63479-0219", "63479-0204", "63479-0221", "63479-0213", "63479-0206", "63479-0207", "63479-0214", "63479-0208", "63479-0203", "63479-0209", "63479-0211", "63479-0220", "63479-0202" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "SUBLINGUAL", "TOPICAL" ], "substance_name": [ "BOS TAURUS PITUITARY GLAND, POSTERIOR", "EPINEPHRINE", "GLYCERIN", "GLYCYRRHIZA GLABRA", "LACTIC ACID, DL-", "LACTIC ACID, L-", "LACTOSE, UNSPECIFIED FORM", "MAGNESIUM SULFATE HEPTAHYDRATE", "NICKEL", "PANCRELIPASE", "PHOSPHORIC ACID", "POTASSIUM CARBONATE", "SACCHARIN", "SELENIUM", "SILVER NITRATE", "SUCROSE", "SYZYGIUM CUMINI SEED", "THYROID, UNSPECIFIED", "ZINC", "ACHILLEA MILLEFOLIUM", "ACONITUM NAPELLUS", "APIS MELLIFERA", "ARNICA MONTANA", "ARSENIC TRIOXIDE", "ATROPA BELLADONNA", "BELLIS PERENNIS", "BRYONIA ALBA ROOT", "CALENDULA OFFICINALIS FLOWERING TOP", "CITRULLUS COLOCYNTHIS FRUIT PULP", "CLEMATIS VITALBA FLOWER", "COMFREY ROOT", "ECHINACEA ANGUSTIFOLIA", "ECHINACEA PURPUREA", "EUPATORIUM PERFOLIATUM FLOWERING TOP", "FERROSOFERRIC PHOSPHATE", "HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK", "HELIANTHEMUM NUMMULARIUM FLOWER", "HISTAMINE DIHYDROCHLORIDE", "HYPERICUM PERFORATUM", "IMPATIENS GLANDULIFERA FLOWER", "MATRICARIA CHAMOMILLA", "ORNITHOGALUM UMBELLATUM FLOWERING TOP", "PRUNUS CERASIFERA FLOWER", "SOLANUM DULCAMARA WHOLE", "SULFUR", "TOXICODENDRON PUBESCENS LEAF", "VERATRUM ALBUM ROOT", "LEDUM PALUSTRE TWIG", "MATRICARIA CHAMOMILLA WHOLE", "MENTHA PIPERITA", "PLANTAGO MAJOR", "VERBASCUM THAPSUS", "ACTIVATED CHARCOAL", "ALFALFA", "ANTIMONY TRISULFIDE", "AVENA SATIVA FLOWERING TOP", "BERBERIS VULGARIS ROOT BARK", "BOS TAURUS BILE", "CAJUPUT OIL", "CARBO ANIMALIS", "CHELIDONIUM MAJUS", "FRANGULA PURSHIANA BARK", "GENTIANA LUTEA ROOT", "INDOLE", "LYCOPODIUM CLAVATUM SPORE", "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE", "PEPSIN", "RADISH", "SKATOLE", "STAR ANISE", "STRYCHNOS NUX-VOMICA SEED", "CALCIUM FLUORIDE", "CALCIUM SULFATE ANHYDROUS", "FERROUS IODIDE", "GARLIC", "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "POTASSIUM PHOSPHATE, DIBASIC", "SODIUM CHLORIDE", "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE", "TRIBASIC CALCIUM PHOSPHATE", "URTICA URENS", "ARABICA COFFEE BEAN", "CARPINUS BETULUS FLOWER", "DIBASIC POTASSIUM PHOSPHATE", "ESCHSCHOLZIA CALIFORNICA", "FICUS CARICA FLOWER BUD", "HOPS", "MELISSA OFFICINALIS", "PASSIFLORA INCARNATA FLOWERING TOP", "POTASSIUM SILICATE", "QUERCUS ROBUR FLOWER", "STRYCHNOS IGNATII SEED", "SUS SCROFA PARASYMPATHETIC NERVE", "SUS SCROFA PINEAL GLAND", "SUS SCROFA SYMPATHETIC NERVE", "VALERIAN", "VERBENA OFFICINALIS FLOWERING TOP", "ZINC VALERATE DIHYDRATE", "AETHUSA CYNAPIUM", "CASTANEA SATIVA FLOWER", "CERATOSTIGMA WILLMOTTIANUM FLOWER", "CHASTE TREE", "GOLD", "MANDRAGORA OFFICINARUM ROOT", "POPULUS TREMULA FLOWERING TOP", "ROSA CANINA FLOWER", "SEPIA OFFICINALIS JUICE", "SINAPIS ARVENSIS FLOWERING/FRUITING TOP", "TURNERA DIFFUSA LEAFY TWIG", "ULEX EUROPAEUS FLOWER", "BLATTA ORIENTALIS", "COPPER", "CORALLIUM RUBRUM EXOSKELETON", "COW MILK", "DROSERA ROTUNDIFOLIA", "GOLDENSEAL", "HEDERA HELIX FLOWERING TWIG", "HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED", "IPECAC", "LOBELIA INFLATA", "POTASSIUM NITRATE", "PROTORTONIA CACTI", "SAMBUCUS NIGRA FLOWERING TOP", "THYMUS SERPYLLUM", "BALSAM PERU", "CALCIUM ACETATE", "CALOMEL", "EUCALYPTUS GLOBULUS LEAF", "EUPHORBIA RESINIFERA RESIN", "EUPHRASIA STRICTA", "LUFFA OPERCULATA FRUIT", "MERCURIC CYANIDE", "MERCURIC SULFIDE", "POTASSIUM DICHROMATE", "SANGUINARINE NITRATE", "SAPONARIA OFFICINALIS ROOT", "SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE", "SODIUM BORATE", "CALCIUM IODIDE", "CALCIUM SULFIDE", "ONION", "PHOSPHORUS", "POTASSIUM CHLORIDE", "POTASSIUM SULFATE", "PULSATILLA VULGARIS", "SKIM MILK", "THUJA OCCIDENTALIS LEAFY TWIG", "BAPTISIA TINCTORIA ROOT", "GELSEMIUM SEMPERVIRENS ROOT", "INFLUENZA A VIRUS WHOLE", "LACHESIS MUTA VENOM", "OLEA EUROPAEA FLOWER", "ARISTOLOCHIA CYMBIFERA FLOWER", "RUTA GRAVEOLENS FLOWERING TOP", "SULFUR IODIDE", "ACONITUM NAPELLUS WHOLE", "RHODODENDRON TOMENTOSUM LEAFY TWIG", "ACETIC ACID", "AMERICAN GINSENG", "CINCHONA OFFICINALIS BARK", "QUININE ARSENITE" ], "spl_id": [ "0e769c02-e362-91a1-e063-6394a90a42b9", "0e76a879-b2c6-dcc6-e063-6294a90ac60e", "47429919-70f8-cbab-e063-6394a90a5376", "0e76a879-b2c8-dcc6-e063-6294a90ac60e", "4742a0ff-3052-b425-e063-6294a90a556e", "0e768a0e-1c63-7a5b-e063-6394a90a8097", "0e769c02-e363-91a1-e063-6394a90a42b9", "0e768a0e-1c4f-7a5b-e063-6394a90a8097", "0e765edc-2648-533a-e063-6394a90a7c53", "0e765edc-2644-533a-e063-6394a90a7c53", "47428a99-4994-566c-e063-6294a90a939b", "0e765edc-2645-533a-e063-6394a90a7c53", "0e768a0e-1c52-7a5b-e063-6394a90a8097", "0e8b3606-7e0b-af78-e063-6294a90afbd2", "0e769d13-23f1-f61f-e063-6294a90a8cd1" ], "spl_set_id": [ "bae9ff7e-eb69-c61d-e053-2995a90a2627", "4ce96ca9-8964-4b60-9d99-bf01d3d1cb43", "beeb9628-2366-a8c2-e053-2995a90a508d", "bad8bfa1-a882-65b1-e053-2995a90a02f7", "16c76a4d-7085-f8f5-e063-6294a90a5b37", "bf78b0b0-5b7b-28cb-e053-2a95a90a1e7d", "baeb5252-49b5-149c-e053-2995a90a2000", "bd1fbb76-4f6f-7098-e053-2a95a90ae25c", "beeaca49-a683-7e57-e053-2995a90ac04f", "bf8e9d3a-b633-8cf2-e053-2995a90a0930", "bad83f77-e9ae-7118-e053-2a95a90aa737", "bed7fba6-605c-4696-e053-2a95a90a457f", "baecce61-0514-abe5-e053-2995a90a12a8", "bccc6476-4987-b1a0-e053-2995a90a5a02", "bad63b2e-63b4-ee97-e053-2a95a90a82e4" ], "package_ndc": [ "63479-0205-1", "63479-0201-1", "63479-0219-1", "63479-0204-1", "63479-0221-1", "63479-0213-1", "63479-0206-1", "63479-0207-1", "63479-0214-1", "63479-0208-1", "63479-0203-1", "63479-0209-1", "63479-0211-1", "63479-0220-1", "63479-0202-1" ], "nui": [ "N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647", "N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417", "N0000185371", "N0000185375", "M0006342", "M0016962", "N0000185508", "N0000185021", "M0002274", "M0022575", "M0516536", "M0008672", "N0000185365", "M0028968", "M0005152", "N0000175831", "N0000008595", "N0000008924", "N0000175830", "M0013890" ], "pharm_class_moa": [ "Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]" ], "pharm_class_epc": [ "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]", "Catecholamine [EPC]", "Non-Standardized Chemical Allergen [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Standardized Chemical Allergen [EPC]", "Standardized Insect Venom Allergenic Extract [EPC]", "Non-Standardized Insect Allergenic Extract [EPC]", "Copper-containing Intrauterine Device [EPC]" ], "pharm_class_cs": [ "Catecholamines [CS]", "Allergens [CS]", "Glycerol [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Bee Venoms [CS]", "Vegetable Proteins [CS]", "Seed Storage Proteins [CS]", "Food Additives [CS]", "Insect Proteins [CS]", "Copper [CS]", "Milk Proteins [CS]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]", "Decreased Embryonic Implantation [PE]", "Decreased Sperm Motility [PE]", "Inhibit Ovum Fertilization [PE]" ], "unii": [ "7JM57I419K", "YKH834O4BH", "PDC6A3C0OX", "2788Z9758H", "3B8D35Y7S4", "F9S9FFU82N", "J2B2A4N98G", "SK47B8698T", "7OV03QG267", "FQ3DRG0N5K", "E4GA8884NN", "BQN1B9B9HA", "FST467XS7D", "H6241UJ22B", "95IT3W8JZE", "C151H8M554", "820LSF646I", "0B4FDL9I6P", "J41CSQ7QDS", "2FXJ6SW4PK", "U0NQ8555JD", "7S82P3R43Z", "O80TY208ZW", "S7V92P67HO", "WQZ3G9PF0H", "2HU33I03UY", "T7J046YI2B", "18E7415PXQ", "23H32AOH17", "7SCP4N87CI", "M9VVZ08EKQ", "VB06AV5US8", "QI7G114Y98", "1W0775VX6E", "91GQH8I5F7", "T7S323PKJS", "51BRR32WPP", "3POA0Q644U", "XK4IUX8MNB", "AJU5O1A5ZV", "G0R4UBI2ZZ", "CZD6M4PY4B", "0KD7R09EAS", "G72JA9DHK5", "70FD1KFU70", "6IO182RP7A", "QNS6W5US1Z", "877L01IZ0P", "79M2M2UDA9", "W2469WNO6U", "C9TD27U172", "2P3VWU3H10", "DJO934BRBD", "F79059A38U", "MA9CQJ3F7F", "1TH8Q20J0U", "ET3651ZLOU", "J3TO6BUQ37", "279O8I0433", "7E889U5RNN", "4VBP01X99F", "S72O3284MS", "8724FJW4M5", "C88X29Y479", "HF539G9L3Q", "GID333S43J", "EM5RP35463", "9W945B5H7R", "XKC1657P78", "269XH13919", "O3B55K4YKI", "E934B3V59H", "F5452U54PN", "V1V998DC17", "2E32821G6I", "CI71S98N1Z", "451W47IQ8X", "70WT22SF4B", "91D9GV0Z28", "IHN2NQ5OF9", "3SW678MX72", "07YL55QKZ9", "9315HN272X", "8I2PXY292P", "01G73H6H83", "YF70189L0N", "CLF5YFS11O", "J86L1GUL6K", "ML644HED2V", "1NM3M2487K", "5AZZ2GHR69", "050QZ2EDK7", "H6L0IFR3FE", "JWF5YAW3QW", "311PNK9CDZ", "MN0RX54EQA", "M6936L953C", "YHZ719F7M3", "TP69J995TW", "433OSF3U8A", "79Y1949PYO", "I2XCB174VB", "5Q01F7TPJJ", "81MCR2UQ6Q", "QDL83WN8C2", "WWX61E1ZAK", "RQ2CFA7WWJ", "398DBS1PXN", "535787266D", "789U1901C5", "2CA71K0DLE", "917J3173FT", "QR44N9XPJQ", "ZW3Z11D0JV", "3D10KUA6BM", "U364V64HUN", "62I3C8233L", "9PP1T3TC5U", "RU45X2JN0Z", "LZB7TFX1LT", "CT03BSA18U", "86H4S6K51N", "8P5F881OCY", "Y882YXF34X", "J2D46N657D", "S546YLW6E6", "1TI1O9028K", "C9642I91WL", "C4MO6809HU", "RWG7BD1032", "ZI0T668SF1", "T4423S18FM", "BOP122S791", "RI2K1BMA8B", "90ZQ7G407W", "91MBZ8H3QO", "8EKI9QEE2H", "1MBW07J51Q", "492225Q21H", "27YLU75U4W", "660YQ98I10", "1K573LC5TV", "I76KB35JEV", "6A001Y4M5A", "1NT28V9397", "5EF0HWI5WU", "639KR60Q1Q", "R9HH0NDE2E", "VSW71SS07I", "498M34P1VZ", "R06VWT372T", "N94C2U587S", "L6L8KA2AA0", "Q40Q9N063P", "8W75VCV53Q", "S003A158SB", "42QO5P0NLM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMINS", "activesubstance": { "activesubstancename": "VITAMINS" } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN C", "activesubstance": { "activesubstancename": "ASCORBIC ACID" }, "openfda": { "application_number": [ "M001" ], "brand_name": [ "VITAMIN C SERUM" ], "generic_name": [ "VITAMIN C" ], "manufacturer_name": [ "FlexiGo Inc" ], "product_ndc": [ "85524-2627" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "ASCORBIC ACID", "HYALURONIC ACID", "NIACINAMIDE" ], "spl_id": [ "496e7d41-2177-7b0c-e063-6394a90a98f1" ], "spl_set_id": [ "496e7d41-2176-7b0c-e063-6394a90a98f1" ], "package_ndc": [ "85524-2627-1", "85524-2627-2", "85524-2627-3", "85524-2627-4", "85524-2627-5", "85524-2627-6" ], "nui": [ "N0000193618", "M0001797" ], "pharm_class_epc": [ "Vitamin C [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]" ], "unii": [ "PQ6CK8PD0R", "S270N0TRQY", "25X51I8RD4" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HAIR GROWTH", "activesubstance": { "activesubstancename": "BLACK PEPPER\\COLLAGEN, SOLUBLE, FISH SKIN\\EQUISETUM ARVENSE TOP\\POLYGONUM CUSPIDATUM ROOT\\SAW PALMET" }, "openfda": { "application_number": [ "505G(a)(3)" ], "brand_name": [ "HAIR GROWTH", "SNIDIN", "LYRA ROSEMARY HAIR GROWTH CREAM" ], "generic_name": [ "THUJA ORIENTALIS LEAF", "HAIR GROWTH", "SAW PALMETTO, BLACK PEPPER, REYNOUTRIA JAPONICA ROOT, EQUISETUM ARVENSE TOP, MARINE COLLAGEN, SOLUBLE" ], "manufacturer_name": [ "Guangdong Bisutang Biotechnology Co., Ltd.", "Guangdong Miaolian Cosmetics Co., Ltd.", "Rida LLC", "Dongguan Haiyi Cosmetics Co., Ltd." ], "product_ndc": [ "84753-057", "84507-038", "83004-002", "85594-009" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL", "ORAL", "CUTANEOUS" ], "substance_name": [ "BIOTIN", "DIAMINOPYRIMIDINE OXIDE", "PLATYCLADUS ORIENTALIS LEAF", "PYRROLIDINYL DIAMINOPYRIMIDINE OXIDE", "BLACK PEPPER", "EQUISETUM ARVENSE TOP", "MARINE COLLAGEN, SOLUBLE", "REYNOUTRIA JAPONICA ROOT", "SAW PALMETTO", "BRASSICA ALBA SPROUT" ], "spl_id": [ "4e75ec22-155d-cc79-e063-6394a90a1479", "38619d96-814e-71ee-e063-6294a90af33e", "2fc157a5-c6e2-24fa-e063-6394a90aaeb6", "43dbbe3c-7537-5bf3-e063-6394a90a73ce" ], "spl_set_id": [ "4e75ec22-155c-cc79-e063-6394a90a1479", "38619d96-814d-71ee-e063-6294a90af33e", "8a70d9c8-a178-4369-b2ef-fc7e400f897a", "43dbbe3c-7536-5bf3-e063-6394a90a73ce" ], "package_ndc": [ "84753-057-01", "84507-038-01", "83004-002-01", "85594-009-00" ], "unii": [ "6SO6U10H04", "1756681479", "32E5V7G32B", "23GGI87A7F", "KM66971LVF", "1DP6Y6B65Z", "8JC99XGU4W", "7TRV45YZF7", "J7WWH9M8QS", "Q6RX89ZSB3" ], "nui": [ "N0000185371", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0022575" ], "pharm_class_epc": [ "Non-Standardized Food Allergenic Extract [EPC]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]" ], "pharm_class_cs": [ "Allergens [CS]", "Dietary Proteins [CS]", "Vegetable Proteins [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NATURE^S BOUNTY" }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D3", "activesubstance": { "activesubstancename": "CHOLECALCIFEROL" }, "openfda": { "application_number": [ "ANDA090455" ], "brand_name": [ "VITAMIN D" ], "generic_name": [ "ERGOCALCIFEROL" ], "manufacturer_name": [ "Strides Pharma Science Limited" ], "product_ndc": [ "64380-737" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ERGOCALCIFEROL" ], "rxcui": [ "1367410" ], "spl_id": [ "1cc589f7-cd6d-40a6-8fce-c965e8945eae" ], "spl_set_id": [ "2c4c0a36-12cf-444d-9d57-de983eef4d36" ], "package_ndc": [ "64380-737-06", "64380-737-25" ], "nui": [ "M0007651", "N0000175909" ], "pharm_class_cs": [ "Ergocalciferols [CS]" ], "pharm_class_epc": [ "Provitamin D2 Compound [EPC]" ], "unii": [ "VS041H42XC" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20241021" } } } ] }