| Drug NDC: | 55714-4805 |
| 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: | Heavy Metal-amalga Detox |
| 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: | Allium Sativum, Aluminium Metallicum, Arg. Met., Aur. Met., Baryta Carb., Beryllium Metallicum, Bismuthum Metallicum, Cadmium Metallicum, Calc. Fluor., Carbo Veg., Chelidonium Majus, Cinchona, Cobaltum Met., Cuprum Met., Glycyrrhiza Glabra, Hydrofluoricum Acidum, Iris Versicolor, Manganum Metallicum, Merc. Viv., Niccolum Metallicum, Osmium Metallicum, Platinum Met., Plumb. Met., Stannum Met., Strontium Carb., Thallium Metallicum, Titanium Metallicum, Carduus Mar., Taraxacum |
| 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: | ACTIVATED CHARCOAL - 20 [hp_X]/mL ALUMINUM - 20 [hp_X]/mL BARIUM CARBONATE - 20 [hp_X]/mL BERYLLIUM - 21 [hp_X]/mL BISMUTH - 20 [hp_X]/mL CADMIUM - 20 [hp_X]/mL CALCIUM FLUORIDE - 20 [hp_X]/mL CHELIDONIUM MAJUS - 20 [hp_X]/mL CINCHONA OFFICINALIS BARK - 20 [hp_X]/mL COBALT - 20 [hp_X]/mL Load more... COPPER - 20 [hp_X]/mL GARLIC - 20 [hp_X]/mL GLYCYRRHIZA GLABRA - 21 [hp_X]/mL GOLD - 20 [hp_X]/mL HYDROFLUORIC ACID - 20 [hp_X]/mL IRIS VERSICOLOR ROOT - 20 [hp_X]/mL LEAD - 20 [hp_X]/mL MANGANESE - 20 [hp_X]/mL MERCURY - 20 [hp_X]/mL MILK THISTLE - 20 [hp_X]/mL NICKEL - 20 [hp_X]/mL OSMIUM - 21 [hp_X]/mL PLATINUM - 20 [hp_X]/mL SILVER NITRATE - 20 [hp_X]/mL STRONTIUM CARBONATE - 21 [hp_X]/mL TARAXACUM OFFICINALE - 11 [hp_X]/mL THALLIUM - 20 [hp_X]/mL TIN - 20 [hp_X]/mL TITANIUM - 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: | N0000185508 N0000175629 N0000184306 M0000728 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185371 M0006342 M0016962 N0000185375 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 CPD4NFA903 6P669D8HQ8 OW5102UV6N U015TT5I8H 00BH33GNGH O3B55K4YKI 7E889U5RNN S003A158SB 3G0H8C9362 Load more... 789U1901C5 V1V998DC17 2788Z9758H 79Y1949PYO RGL5YE86CZ X43D4L3DQC 2P299V784P 42Z2K6ZL8P FXS1BY2PGL U946SH95EE 7OV03QG267 2E7M255OPY 49DFR088MY 95IT3W8JZE 41YPU4MMCA 39981FM375 AD84R52XLF 387GMG9FH5 D1JT611TNE |
| 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 Chemical Allergen [EPC] Copper-containing Intrauterine Device [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] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [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] Copper [CS] Dietary Proteins [CS] Plant 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] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Inhibit Ovum Fertilization [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Standardized Chemical Allergen [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 |
|---|---|---|---|---|
| 55714-4805-1 | 30 mL in 1 BOTTLE, GLASS (55714-4805-1) | 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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