| Drug NDC: | 55714-2423 |
| 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: | Dust-mold-dander |
| 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: | Iris Versicolor, Solidago Virgaurea, Antimonium Crudum, Apis Mellifica, Arsenicum Album, Baptisia Tinctoria, Blatta Orientalis, Bromium, Bryonia, Candida Albicans, Carduus Benedictus, Cat Hair, Chelidonium Majus, Cinchona Officinalis, Dog Hair, Histaminum Hydrochloricum, House Dust, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Podophyllum Peltatum, Rhus Toxicodendron, Secale Cornutum, Silicea, Ustilago Maidis, Torula Cerevisiae. |
| 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: | ANTIMONY TRISULFIDE - 15 [hp_X]/g APIS MELLIFERA - 15 [hp_X]/g ARSENIC TRIOXIDE - 15 [hp_X]/g BAPTISIA TINCTORIA ROOT - 15 [hp_X]/g BLATTA ORIENTALIS - 15 [hp_X]/g BROMINE - 15 [hp_X]/g BRYONIA ALBA ROOT - 15 [hp_X]/g CANDIDA ALBICANS - 15 [hp_X]/g CANIS LUPUS FAMILIARIS HAIR - 15 [hp_X]/g CENTAUREA BENEDICTA - 15 [hp_X]/g Load more... CHELIDONIUM MAJUS - 15 [hp_X]/g CINCHONA OFFICINALIS BARK - 15 [hp_X]/g CLAVICEPS PURPUREA SCLEROTIUM - 15 [hp_X]/g FELIS CATUS HAIR - 15 [hp_X]/g HISTAMINE DIHYDROCHLORIDE - 15 [hp_X]/g HOUSE DUST - 15 [hp_X]/g IPECAC - 15 [hp_X]/g IRIS VERSICOLOR ROOT - 6 [hp_X]/g LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/g PODOPHYLLUM - 15 [hp_X]/g SACCHAROMYCES CEREVISIAE - 16 [hp_X]/g SILICON DIOXIDE - 15 [hp_X]/g SOLIDAGO VIRGAUREA FLOWERING TOP - 6 [hp_X]/g STRYCHNOS NUX-VOMICA SEED - 15 [hp_X]/g TOXICODENDRON PUBESCENS LEAF - 15 [hp_X]/g USTILAGO MAYDIS - 15 [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: | 24 Dec, 2025 |
| 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 N0000185365 M0028968 N0000185372 M0008890 N0000185363 M0370530 N0000185003 M0576325 M0515971 N0000185374 M0006896 N0000185371 M0006342 N0000185375 M0016962 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | F79059A38U 7S82P3R43Z S7V92P67HO 5EF0HWI5WU 535787266D SBV4XY874G T7J046YI2B 4D7G21HDBC 05S7L91ZTR 6L5ZL09795 Load more... 7E889U5RNN S003A158SB 01G9XEA93N 1564HD0N96 3POA0Q644U EYO007VX98 62I3C8233L X43D4L3DQC C88X29Y479 2S713A4VP3 978D8U419H ETJ7Z6XBU4 5405K23S50 269XH13919 6IO182RP7A 4K7Z7K7SWG |
| 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 Insect Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Animal Hair Allergenic Extract [EPC] Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized House Dust Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant 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] Insect Proteins [CS] Fungal Proteins [CS] Animal Fur [CS] Dander [CS] Salivary Proteins and Peptides [CS] House Dust [CS] Dietary Proteins [CS] Plant Proteins [CS] Seed Storage 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] Bee Venoms [CS] Cell-mediated Immunity [PE] Dander [CS] Dietary Proteins [CS] Fungal Proteins [CS] House Dust [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Insect 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 Insect Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [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] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 55714-2423-1 | 28 g in 1 BOTTLE, GLASS (55714-2423-1) | 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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