| PRODUCT NDC | 55714-2562 | The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| PRODUCT TYPE NAME | HUMAN OTC DRUG | Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing. |
| PROPRIETARY NAME | Hay Fever | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| NON PROPRIETARY NAME | Apis mellifica, Echinacea, Hydrastis canadensis, Taraxacum officinale, Aconitum napellus, Alfalfa, Allium cepa, Ambrosia artemisiaefolia, Ammonium carbonicum, Aralia racemosa, Arsenicum album, Artemisia vulgaris, Arundo mauritanica, Bellis perennis, Berberis vulgaris, Bryonia, Calluna vulgaris, flos, Chelidonium majus, Chenopodium anthelminticum, Cistus canadensis, Drosera, Dulcamara, Eupatorium perfoliatum, Euphrasia officinalis, Fagus sylvatica, Fraxinus americana, Gelsemium sempervirens | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| DOSAGE FORM NAME | LIQUID | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 5/18/2020 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| MARKETING CATEGORY NAME | UNAPPROVED HOMEOPATHIC | Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| LABELER NAME | Newton Laboratories, Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | ACONITUM NAPELLUS; ALFALFA; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ANEMONE PULSATILLA; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; ARUNDO PLINIANA ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALLUNA VULGARIS FLOWERING TOP; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DROSERA ANGLICA; DYSPHANIA AMBROSIOIDES; ECHINACEA, UNSPECIFIED; ELYMUS REPENS ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FAGUS SYLVATICA NUT; FRAXINUS AMERICANA BARK; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ONION; ONOSMODIUM VIRGINIANUM; PARTHENIUM HYSTEROPHORUS; POPULUS BALSAMIFERA LEAF BUD; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; QUERCUS ROBUR NUT; RHODODENDRON TOMENTOSUM LEAFY TWIG; ROSA X DAMASCENA FLOWERING TOP; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRILLIUM ERECTUM ROOT; ULMUS RUBRA BARK; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES | An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted. |
| ACTIVE NUMERATOR STRENGTH | 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 16; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 16; 15; 15; 15; 15 | |
| ACTIVE INGRED UNIT | [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_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_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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL | |
| PHARM CLASSES | Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS] | |