| Drug NDC: | 55714-4804 |
| 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: | Pollen-weeds |
| 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: | Ginkgo Biloba, Hydrastis Canadensis, Taraxacum Officinale, Adrenalinum , Aletris Farinosa, Alfalfa, Allium Cepa, Antimonium Tartaricum, Arsenicum Album, Artemisia Vulgaris, Baptisia Tinctoria, Bellis Perennis, Berberis Vulgaris, Bryonia, Calluna Vulgaris, Flos, Chelidonium Majus, Chenopodium Anthelminticum, Dioscorea Vilosa, Euphrasia Officinalis, Fagus Sylvatica, Fraxinus Americana, Gelsemium Sempervirens, Histaminum Hydrochloricum, Kali Bichromicum, Kali Iodatum, Lachesis Mutus, Lilium Tigrinum, |
| 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: | ALETRIS FARINOSA ROOT - 20 [hp_X]/mL ALFALFA - 20 [hp_X]/mL ANEMONE PULSATILLA - 20 [hp_X]/mL ANTIMONY POTASSIUM TARTRATE - 20 [hp_X]/mL ARSENIC TRIOXIDE - 20 [hp_X]/mL ARTEMISIA VULGARIS ROOT - 20 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 20 [hp_X]/mL BELLIS PERENNIS - 20 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 20 [hp_X]/mL BRYONIA ALBA ROOT - 20 [hp_X]/mL Load more... CALLUNA VULGARIS FLOWERING TOP - 20 [hp_X]/mL CHELIDONIUM MAJUS - 20 [hp_X]/mL DIOSCOREA VILLOSA TUBER - 20 [hp_X]/mL DYSPHANIA AMBROSIOIDES - 20 [hp_X]/mL ELYMUS REPENS ROOT - 20 [hp_X]/mL EPINEPHRINE - 20 [hp_X]/mL EUPHRASIA STRICTA - 20 [hp_X]/mL FAGUS SYLVATICA NUT - 20 [hp_X]/mL FRAXINUS AMERICANA BARK - 20 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 20 [hp_X]/mL GINKGO - 11 [hp_X]/mL GOLDENSEAL - 11 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 20 [hp_X]/mL JUNIPERUS VIRGINIANA TWIG - 21 [hp_X]/mL LACHESIS MUTA VENOM - 20 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING - 20 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 20 [hp_X]/mL LYCOPUS VIRGINICUS - 20 [hp_X]/mL ONION - 20 [hp_X]/mL PARTHENIUM HYSTEROPHORUS - 21 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 20 [hp_X]/mL POPULUS BALSAMIFERA LEAF BUD - 20 [hp_X]/mL POPULUS TREMULOIDES LEAF - 20 [hp_X]/mL POTASSIUM DICHROMATE - 20 [hp_X]/mL POTASSIUM IODIDE - 20 [hp_X]/mL PTELEA TRIFOLIATA BARK - 20 [hp_X]/mL QUERCUS ROBUR NUT - 20 [hp_X]/mL ROSA DAMASCENA FLOWERING TOP - 20 [hp_X]/mL SALIX NIGRA BARK - 20 [hp_X]/mL SAMBUCUS NIGRA FLOWERING TOP - 20 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED - 20 [hp_X]/mL TARAXACUM OFFICINALE - 11 [hp_X]/mL THYROID, UNSPECIFIED - 20 [hp_X]/mL TRIFOLIUM PRATENSE FLOWER - 20 [hp_X]/mL TRILLIUM ERECTUM ROOT - 20 [hp_X]/mL ULMUS RUBRA BARK - 21 [hp_X]/mL URTICA URENS - 20 [hp_X]/mL USTILAGO MAYDIS - 20 [hp_X]/mL WYETHIA HELENIOIDES ROOT - 20 [hp_X]/mL XEROPHYLLUM ASPHODELOIDES - 20 [hp_X]/mL YUCCA FILAMENTOSA - 21 [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: | 02 Sep, 2019 |
| 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: | N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 N0000185372 N0000185001 M0008890 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | O021JGR97X DJO934BRBD I76KB35JEV DL6OZ476V3 S7V92P67HO 32MP823R8S 5EF0HWI5WU 2HU33I03UY 1TH8Q20J0U T7J046YI2B Load more... D9PC510CQV 7E889U5RNN IWY3IWX2G8 4H5RSU087I 3IXW0F6P8W YKH834O4BH C9642I91WL I57ERU2601 0B24UR1O1S 639KR60Q1Q 19FUJ2C58T ZW3Z11D0JV 3POA0Q644U 532BCG080L VSW71SS07I X67Z2963PI C88X29Y479 TWH5125Q6F 492225Q21H 151F45R21P 11E6VI8VEG 9CQ6C00G3C 7IIH57D9E0 T4423S18FM 1C4QK22F9J 5KQR6FTT0D Q7MU1F4GLY 21W82Q764G QU52J3A5B3 CT03BSA18U 6NAF1689IO 39981FM375 0B4FDL9I6P 4JS0838828 AHW6F0T2X0 91QY4PXU8Q IHN2NQ5OF9 4K7Z7K7SWG J10PD1AQ0N 9I4XB1GP2B T6VR38UJ9I |
| 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 MOA: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] Catecholamine [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: | Catecholamines [CS] Allergens [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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Allergens [CS] Catecholamine [EPC] Catecholamines [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Vegetable Proteins [CS] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 55714-4804-1 | 30 mL in 1 BOTTLE, GLASS (55714-4804-1) | 02 Sep, 2019 | 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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