| Drug NDC: | 55714-4832 |
| 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: | Dairy-grain-nightshade |
| 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 Vers., Solidago, Antimon. Crud., Arg. Nit., Arsenicum Alb., Avena, Baptisia, Belladonna, Bryonia, Capsicum, Carduus Ben., Cinchona, Dulcamara, Fagopyrum, Gelsemium, Hyoscyamus, Ipecac., Lac Vac., Lachesis, Lycopodium, Nat. Mur., Phos., Podoph. Pelt., Pulsatilla, Rhus Tox., Sac. Lac., Secale, Sepia, Stramonium, Tabacum, Triticum, Ustilago Maidis, Verbascum, Lycopersicum, Solanum Nig., Solanum Tub., Stigmata, 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: | 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: | ANEMONE PULSATILLA - 15 [hp_X]/mL ANTIMONY TRISULFIDE - 15 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL ATROPA BELLADONNA - 15 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 15 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CAPSICUM - 15 [hp_X]/mL CENTAUREA BENEDICTA - 15 [hp_X]/mL CINCHONA OFFICINALIS BARK - 15 [hp_X]/mL Load more... CLAVICEPS PURPUREA SCLEROTIUM - 15 [hp_X]/mL CORN SILK - 16 [hp_X]/mL COW MILK - 15 [hp_X]/mL DATURA STRAMONIUM - 15 [hp_X]/mL ELYMUS REPENS ROOT - 15 [hp_X]/mL FAGOPYRUM ESCULENTUM - 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 15 [hp_X]/mL HYOSCYAMUS NIGER - 15 [hp_X]/mL IPECAC - 15 [hp_X]/mL IRIS VERSICOLOR ROOT - 6 [hp_X]/mL LACHESIS MUTA VENOM - 15 [hp_X]/mL LACTOSE, UNSPECIFIED FORM - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/mL PHOSPHORUS - 15 [hp_X]/mL PODOPHYLLUM - 15 [hp_X]/mL SACCHAROMYCES CEREVISIAE - 16 [hp_X]/mL SEPIA OFFICINALIS JUICE - 15 [hp_X]/mL SILVER NITRATE - 15 [hp_X]/mL SODIUM CHLORIDE - 15 [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 SOLIDAGO VIRGAUREA FLOWERING TOP - 6 [hp_X]/mL TOBACCO LEAF - 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 15 [hp_X]/mL USTILAGO MAYDIS - 15 [hp_X]/mL VERBASCUM THAPSUS - 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: | 02 Sep, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 09 May, 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: | N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 M0013890 N0000185372 N0000185001 M0008890 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | I76KB35JEV F79059A38U S7V92P67HO WQZ3G9PF0H MA9CQJ3F7F 5EF0HWI5WU T7J046YI2B 00UK7646FG 6L5ZL09795 S003A158SB Load more... 01G9XEA93N 7D3VB244UX 917J3173FT G6W4F0V8Z3 3IXW0F6P8W B10M69172N 639KR60Q1Q 4WRK2153H3 62I3C8233L X43D4L3DQC VSW71SS07I J2B2A4N98G C88X29Y479 27YLU75U4W 2S713A4VP3 978D8U419H QDL83WN8C2 95IT3W8JZE 451W47IQ8X KPS1B1162N 0243Q4990L 0FMD6WV47M 2A8I57T4MX 5405K23S50 6YR2608RSU 6IO182RP7A 4K7Z7K7SWG C9TD27U172 |
| 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: | Non-Standardized Plant 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] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] Milk 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] Cell-mediated Immunity [PE] Dietary Proteins [CS] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Milk Proteins [CS] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] 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 |
|---|---|---|---|---|
| 55714-4832-1 | 30 mL in 1 BOTTLE, GLASS (55714-4832-1) | 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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