| Drug 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. | |
| Proprietary Name: | Hay Fever |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Newton Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | ACONITUM NAPELLUS - 15 [hp_X]/mL ALFALFA - 15 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA - 15 [hp_X]/mL AMMONIUM CARBONATE - 15 [hp_X]/mL ANEMONE PULSATILLA - 15 [hp_X]/mL APIS MELLIFERA - 6 [hp_X]/mL ARALIA RACEMOSA ROOT - 15 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL ARTEMISIA VULGARIS ROOT - 15 [hp_X]/mL ARUNDO PLINIANA ROOT - 15 [hp_X]/mL Load more... BELLIS PERENNIS - 15 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CALCIUM SULFIDE - 15 [hp_X]/mL CALLUNA VULGARIS FLOWERING TOP - 15 [hp_X]/mL CHELIDONIUM MAJUS - 15 [hp_X]/mL DATURA STRAMONIUM - 15 [hp_X]/mL DROSERA ANGLICA - 15 [hp_X]/mL DYSPHANIA AMBROSIOIDES - 15 [hp_X]/mL ECHINACEA, UNSPECIFIED - 6 [hp_X]/mL ELYMUS REPENS ROOT - 15 [hp_X]/mL EUPATORIUM PERFOLIATUM FLOWERING TOP - 15 [hp_X]/mL EUPHRASIA STRICTA - 15 [hp_X]/mL FAGUS SYLVATICA NUT - 15 [hp_X]/mL FRAXINUS AMERICANA BARK - 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 15 [hp_X]/mL GOLDENSEAL - 6 [hp_X]/mL HELIANTHEMUM CANADENSE - 15 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 15 [hp_X]/mL LACHESIS MUTA VENOM - 15 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/mL ONION - 15 [hp_X]/mL ONOSMODIUM VIRGINIANUM - 15 [hp_X]/mL PARTHENIUM HYSTEROPHORUS - 16 [hp_X]/mL POPULUS BALSAMIFERA LEAF BUD - 15 [hp_X]/mL POPULUS TREMULOIDES LEAF - 15 [hp_X]/mL POTASSIUM DICHROMATE - 15 [hp_X]/mL POTASSIUM IODIDE - 15 [hp_X]/mL QUERCUS ROBUR NUT - 15 [hp_X]/mL RHODODENDRON TOMENTOSUM LEAFY TWIG - 15 [hp_X]/mL ROSA X DAMASCENA FLOWERING TOP - 15 [hp_X]/mL SALIX NIGRA BARK - 15 [hp_X]/mL SANGUINARIA CANADENSIS ROOT - 15 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED - 15 [hp_X]/mL SODIUM CHLORIDE - 15 [hp_X]/mL SOLANUM DULCAMARA TOP - 15 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 15 [hp_X]/mL TARAXACUM OFFICINALE - 6 [hp_X]/mL TRILLIUM ERECTUM ROOT - 15 [hp_X]/mL ULMUS RUBRA BARK - 16 [hp_X]/mL URTICA URENS - 15 [hp_X]/mL USTILAGO MAYDIS - 15 [hp_X]/mL WYETHIA HELENIOIDES ROOT - 15 [hp_X]/mL XEROPHYLLUM ASPHODELOIDES - 15 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. | |
| Marketing Start Date: | 18 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Newton Laboratories, Inc. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274 N0000185371 M0006342 M0022575 N0000185372 M0008890 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | U0NQ8555JD DJO934BRBD 9W34L2CQ9A NJ5VT0FKLJ I76KB35JEV 7S82P3R43Z T90W4582DU S7V92P67HO 32MP823R8S ZXE7LB03WC Load more... 2HU33I03UY 1TH8Q20J0U T7J046YI2B 1MBW07J51Q D9PC510CQV 7E889U5RNN G6W4F0V8Z3 J61BY05EGY 4H5RSU087I 4N9P6CC1DX 3IXW0F6P8W 1W0775VX6E C9642I91WL I57ERU2601 0B24UR1O1S 639KR60Q1Q ZW3Z11D0JV 46G3W789Q3 3POA0Q644U VSW71SS07I X67Z2963PI C88X29Y479 492225Q21H 604NK4250S 151F45R21P 9CQ6C00G3C 7IIH57D9E0 T4423S18FM 1C4QK22F9J Q7MU1F4GLY 877L01IZ0P 21W82Q764G QU52J3A5B3 N9288CD508 6NAF1689IO 451W47IQ8X KPS1B1162N 5405K23S50 39981FM375 AHW6F0T2X0 91QY4PXU8Q IHN2NQ5OF9 4K7Z7K7SWG J10PD1AQ0N 9I4XB1GP2B |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Pharmacologic Class EPC: | Standardized Insect Venom Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Allergens [CS] Bee Venoms [CS] Dietary Proteins [CS] Vegetable Proteins [CS] Fungal Proteins [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Fungal Proteins [CS] Increased Histamine Release [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] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 55714-2562-1 | 30 mL in 1 BOTTLE, GLASS (55714-2562-1) | 18 May, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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