| Drug NDC: | 55714-1519 |
| 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: | 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: | ABRUS PRECATORIUS SEED - 15 [hp_X]/mL ACONITUM NAPELLUS - 15 [hp_X]/mL AETHUSA CYNAPIUM - 15 [hp_X]/mL ALETRIS FARINOSA ROOT - 15 [hp_X]/mL ALFALFA - 15 [hp_X]/mL ALLYLTHIOUREA - 15 [hp_X]/mL ALPINE STRAWBERRY - 15 [hp_X]/mL AMANITA MUSCARIA FRUITING BODY - 15 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA - 15 [hp_X]/mL ANACARDIUM OCCIDENTALE FRUIT - 16 [hp_X]/mL Load more... ANEMONE PULSATILLA - 15 [hp_X]/mL APIS MELLIFERA - 6 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL ARTEMISIA VULGARIS ROOT - 15 [hp_X]/mL ARUNDO PLINIANA ROOT - 15 [hp_X]/mL ASCORBIC ACID - 16 [hp_X]/mL ASTACUS ASTACUS - 16 [hp_X]/mL ATROPA BELLADONNA - 15 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 15 [hp_X]/mL BELLIS PERENNIS - 15 [hp_X]/mL BLACK MUSTARD SEED - 16 [hp_X]/mL BROMINE - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CAFFEINE - 15 [hp_X]/mL CALLUNA VULGARIS FLOWERING TOP - 15 [hp_X]/mL CANIS LUPUS FAMILIARIS HAIR - 15 [hp_X]/mL CAPSICUM - 15 [hp_X]/mL CHELIDONIUM MAJUS - 15 [hp_X]/mL CINNAMON - 15 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM - 15 [hp_X]/mL CORN SILK - 16 [hp_X]/mL COW MILK - 15 [hp_X]/mL CYNARA SCOLYMUS LEAF - 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 EGG SHELL, COOKED - 15 [hp_X]/mL ELYMUS REPENS ROOT - 15 [hp_X]/mL EUPHRASIA STRICTA - 15 [hp_X]/mL FAGOPYRUM ESCULENTUM - 15 [hp_X]/mL FAGUS SYLVATICA NUT - 15 [hp_X]/mL FELIS CATUS HAIR - 15 [hp_X]/mL FRAXINUS AMERICANA BARK - 15 [hp_X]/mL GARLIC - 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 15 [hp_X]/mL GINGER - 15 [hp_X]/mL GLYCYRRHIZA GLABRA - 16 [hp_X]/mL GOLDENSEAL - 6 [hp_X]/mL HELIANTHEMUM CANADENSE - 15 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 15 [hp_X]/mL HOUSE DUST - 15 [hp_X]/mL HYOSCYAMUS NIGER - 15 [hp_X]/mL JUGLANS REGIA LEAF - 15 [hp_X]/mL JUNIPERUS VIRGINIANA TWIG - 16 [hp_X]/mL LACTOSE, UNSPECIFIED FORM - 15 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING - 15 [hp_X]/mL LYCOPERDON UTRIFORME FRUITING BODY - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/mL LYCOPUS VIRGINICUS - 15 [hp_X]/mL MATRICARIA CHAMOMILLA - 15 [hp_X]/mL MENTHA PIPERITA - 15 [hp_X]/mL NUTMEG - 15 [hp_X]/mL ONION - 15 [hp_X]/mL ONOSMODIUM VIRGINIANUM - 15 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 15 [hp_X]/mL PARTHENIUM HYSTEROPHORUS - 16 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 15 [hp_X]/mL POPULUS BALSAMIFERA LEAF BUD - 15 [hp_X]/mL POPULUS TREMULOIDES LEAF - 15 [hp_X]/mL POTASSIUM IODIDE - 15 [hp_X]/mL PROTORTONIA CACTI - 15 [hp_X]/mL PTELEA TRIFOLIATA BARK - 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 SACCHARIN - 15 [hp_X]/mL SACCHAROMYCES CEREVISIAE - 16 [hp_X]/mL SALIX NIGRA BARK - 15 [hp_X]/mL SAMBUCUS NIGRA FLOWERING TOP - 15 [hp_X]/mL SANGUINARIA CANADENSIS ROOT - 15 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED - 15 [hp_X]/mL SODIUM CHLORIDE - 15 [hp_X]/mL SODIUM NITRATE - 16 [hp_X]/mL SOLANUM DULCAMARA TOP - 15 [hp_X]/mL SOLANUM LYCOPERSICUM - 16 [hp_X]/mL SOLANUM NIGRUM WHOLE - 16 [hp_X]/mL SOLANUM TUBEROSUM - 16 [hp_X]/mL SUCROSE - 16 [hp_X]/mL SULFUR - 15 [hp_X]/mL TARAXACUM OFFICINALE - 6 [hp_X]/mL TOBACCO LEAF - 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 15 [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 YUCCA FILAMENTOSA - 16 [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: | 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: | 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 N0000193618 M0001797 N0000175739 N0000175729 N0000175790 M0023046 N0000185363 M0370530 N0000185375 N0000185371 M0006342 M0016962 M0022575 M0008672 M0013890 N0000185003 M0576325 M0515971 N0000185374 M0006896 M0516536 N0000185372 M0008890 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 3OM8I6L7CD U0NQ8555JD M6936L953C O021JGR97X DJO934BRBD 706IDJ14B7 CG6IX3GCMU DIF093I037 9W34L2CQ9A 4A10JR4E7E Load more... I76KB35JEV 7S82P3R43Z S7V92P67HO 32MP823R8S ZXE7LB03WC PQ6CK8PD0R V0551986XQ WQZ3G9PF0H MA9CQJ3F7F 2HU33I03UY 8LTY55LQ8D SBV4XY874G T7J046YI2B 3G6A5W338E D9PC510CQV 05S7L91ZTR 00UK7646FG 7E889U5RNN 5S29HWU6QB 01G9XEA93N 7D3VB244UX 917J3173FT B71UA545DE G6W4F0V8Z3 J61BY05EGY 4H5RSU087I 4N9P6CC1DX 24HBF856C8 3IXW0F6P8W C9642I91WL B10M69172N I57ERU2601 1564HD0N96 0B24UR1O1S V1V998DC17 639KR60Q1Q C5529G5JPQ 2788Z9758H ZW3Z11D0JV 46G3W789Q3 3POA0Q644U EYO007VX98 4WRK2153H3 85HKB87105 532BCG080L J2B2A4N98G X67Z2963PI K2A74U428F C88X29Y479 TWH5125Q6F G0R4UBI2ZZ 79M2M2UDA9 AEE24M3MQ9 492225Q21H 604NK4250S 2E32821G6I 151F45R21P 11E6VI8VEG 9CQ6C00G3C 7IIH57D9E0 1C4QK22F9J LZB7TFX1LT 5KQR6FTT0D Q7MU1F4GLY 877L01IZ0P 21W82Q764G FST467XS7D 978D8U419H QU52J3A5B3 CT03BSA18U N9288CD508 6NAF1689IO 451W47IQ8X 8M4L3H2ZVZ KPS1B1162N 0243Q4990L 0FMD6WV47M 2A8I57T4MX C151H8M554 70FD1KFU70 39981FM375 6YR2608RSU 6IO182RP7A 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 EPC: | Standardized Insect Venom Allergenic Extract [EPC] Vitamin C [EPC] Central Nervous System Stimulant [EPC] Methylxanthine [EPC] Non-Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized House Dust 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] Central Nervous System Stimulation [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] Ascorbic Acid [CS] Xanthines [CS] Animal Fur [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] Food Additives [CS] Milk Proteins [CS] Dander [CS] Salivary Proteins and Peptides [CS] House Dust [CS] Seed Storage 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] 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 |
|---|---|---|---|---|
| 55714-1519-2 | 50 mL in 1 BOTTLE, GLASS (55714-1519-2) | 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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