| Drug NDC: | 55714-1719 |
| 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: | Allergies |
| 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, 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 |
| 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: | Pellet |
| 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: | ABRUS PRECATORIUS SEED - 15 [hp_X]/g ACONITUM NAPELLUS - 15 [hp_X]/g AETHUSA CYNAPIUM - 15 [hp_X]/g ALETRIS FARINOSA ROOT - 15 [hp_X]/g ALFALFA - 15 [hp_X]/g ALLYLTHIOUREA - 15 [hp_X]/g ALPINE STRAWBERRY - 15 [hp_X]/g AMANITA MUSCARIA FRUITING BODY - 15 [hp_X]/g AMBROSIA ARTEMISIIFOLIA - 15 [hp_X]/g ANACARDIUM OCCIDENTALE FRUIT - 16 [hp_X]/g Load more... ANEMONE PULSATILLA - 15 [hp_X]/g APIS MELLIFERA - 6 [hp_X]/g ARSENIC TRIOXIDE - 15 [hp_X]/g ARTEMISIA VULGARIS ROOT - 15 [hp_X]/g ARUNDO PLINIANA ROOT - 15 [hp_X]/g ASCORBIC ACID - 16 [hp_X]/g ASTACUS ASTACUS - 16 [hp_X]/g ATROPA BELLADONNA - 15 [hp_X]/g AVENA SATIVA FLOWERING TOP - 15 [hp_X]/g BELLIS PERENNIS - 15 [hp_X]/g BLACK MUSTARD SEED - 16 [hp_X]/g BROMINE - 15 [hp_X]/g BRYONIA ALBA ROOT - 15 [hp_X]/g CAFFEINE - 15 [hp_X]/g CALLUNA VULGARIS FLOWERING TOP - 15 [hp_X]/g CANIS LUPUS FAMILIARIS HAIR - 15 [hp_X]/g CAPSICUM - 15 [hp_X]/g CHELIDONIUM MAJUS - 15 [hp_X]/g CINNAMON - 15 [hp_X]/g CLAVICEPS PURPUREA SCLEROTIUM - 15 [hp_X]/g CORN SILK - 16 [hp_X]/g COW MILK - 15 [hp_X]/g CYNARA SCOLYMUS LEAF - 15 [hp_X]/g DATURA STRAMONIUM - 15 [hp_X]/g DROSERA ANGLICA - 15 [hp_X]/g DYSPHANIA AMBROSIOIDES - 15 [hp_X]/g ECHINACEA, UNSPECIFIED - 6 [hp_X]/g EGG SHELL, COOKED - 15 [hp_X]/g ELYMUS REPENS ROOT - 15 [hp_X]/g EUPHRASIA STRICTA - 15 [hp_X]/g FAGOPYRUM ESCULENTUM - 15 [hp_X]/g FAGUS SYLVATICA NUT - 15 [hp_X]/g FELIS CATUS HAIR - 15 [hp_X]/g FRAXINUS AMERICANA BARK - 15 [hp_X]/g GARLIC - 15 [hp_X]/g GELSEMIUM SEMPERVIRENS ROOT - 15 [hp_X]/g GINGER - 15 [hp_X]/g GLYCYRRHIZA GLABRA - 16 [hp_X]/g GOLDENSEAL - 6 [hp_X]/g HELIANTHEMUM CANADENSE - 15 [hp_X]/g HISTAMINE DIHYDROCHLORIDE - 15 [hp_X]/g HOUSE DUST - 15 [hp_X]/g HYOSCYAMUS NIGER - 15 [hp_X]/g JUGLANS REGIA LEAF - 15 [hp_X]/g JUNIPERUS VIRGINIANA TWIG - 16 [hp_X]/g LACTOSE, UNSPECIFIED FORM - 15 [hp_X]/g LILIUM LANCIFOLIUM WHOLE FLOWERING - 15 [hp_X]/g LYCOPERDON UTRIFORME FRUITING BODY - 15 [hp_X]/g LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/g LYCOPUS VIRGINICUS - 15 [hp_X]/g MATRICARIA CHAMOMILLA - 15 [hp_X]/g MENTHA PIPERITA - 15 [hp_X]/g NUTMEG - 15 [hp_X]/g ONION - 15 [hp_X]/g ONOSMODIUM VIRGINIANUM - 15 [hp_X]/g OYSTER SHELL CALCIUM CARBONATE, CRUDE - 15 [hp_X]/g PARTHENIUM HYSTEROPHORUS - 16 [hp_X]/g PHYTOLACCA AMERICANA ROOT - 15 [hp_X]/g POPULUS BALSAMIFERA LEAF BUD - 15 [hp_X]/g POPULUS TREMULOIDES LEAF - 15 [hp_X]/g POTASSIUM IODIDE - 15 [hp_X]/g PROTORTONIA CACTI - 15 [hp_X]/g PTELEA TRIFOLIATA BARK - 15 [hp_X]/g QUERCUS ROBUR NUT - 15 [hp_X]/g RHODODENDRON TOMENTOSUM LEAFY TWIG - 15 [hp_X]/g ROSA X DAMASCENA FLOWERING TOP - 15 [hp_X]/g SACCHARIN - 15 [hp_X]/g SACCHAROMYCES CEREVISIAE - 16 [hp_X]/g SALIX NIGRA BARK - 15 [hp_X]/g SAMBUCUS NIGRA FLOWERING TOP - 15 [hp_X]/g SANGUINARIA CANADENSIS ROOT - 15 [hp_X]/g SCHOENOCAULON OFFICINALE SEED - 15 [hp_X]/g SODIUM CHLORIDE - 15 [hp_X]/g SODIUM NITRATE - 16 [hp_X]/g SOLANUM DULCAMARA TOP - 15 [hp_X]/g SOLANUM LYCOPERSICUM - 16 [hp_X]/g SOLANUM NIGRUM WHOLE - 16 [hp_X]/g SOLANUM TUBEROSUM - 16 [hp_X]/g SUCROSE - 16 [hp_X]/g SULFUR - 15 [hp_X]/g TARAXACUM OFFICINALE - 6 [hp_X]/g TOBACCO LEAF - 15 [hp_X]/g TOXICODENDRON PUBESCENS LEAF - 15 [hp_X]/g TRILLIUM ERECTUM ROOT - 15 [hp_X]/g ULMUS RUBRA BARK - 16 [hp_X]/g URTICA URENS - 15 [hp_X]/g USTILAGO MAYDIS - 15 [hp_X]/g WYETHIA HELENIOIDES ROOT - 15 [hp_X]/g XEROPHYLLUM ASPHODELOIDES - 15 [hp_X]/g YUCCA FILAMENTOSA - 16 [hp_X]/g |
| 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: | 01 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 21 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: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| UNII: | |
| 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: | Allergens [CS] Animal Fur [CS] Ascorbic Acid [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Central Nervous System Stimulant [EPC] Central Nervous System Stimulation [PE] Dander [CS] Dietary Proteins [CS] Food Additives [CS] Fungal Proteins [CS] House Dust [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Methylxanthine [EPC] Milk Proteins [CS] Non-Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized House Dust Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Plant Proteins [CS] Salivary Proteins and Peptides [CS] Seed Storage Proteins [CS] Standardized Animal Hair Allergenic Extract [EPC] Standardized Insect Venom Allergenic Extract [EPC] Vegetable Proteins [CS] Vitamin C [EPC] Xanthines [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 |
|---|---|---|---|---|
| 55714-1719-2 | 48 g in 1 BOTTLE, GLASS (55714-1719-2) | 01 Jan, 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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