| Drug NDC: | 69134-0002 |
| 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: | Lymph Drainage |
| 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: | Baptisia Tinctoria, Citrus Limonum, Echinacea (angustifolia), Lobelia Inflata, Phytolacca Decandra, Pinus Sylvestris, Teucrium Scorodonia, Thuja Occidentalis, Capsicum Annuum, Cuprum Sulphuricum, Kali Muriaticum, Manganum Muriaticum, Arsenicum Iodatum, Carpinus Betulus, Flos, Centaurium Umbellatum, Flos, Galium Aparine, Larix Decidua, Flos, Rosa Canina, Scrophularia Nodosa, Zincum Gluconicum, Aranea Diadema, Calcarea Carbonica, Carbo Vegetabilis, Ceanothus Americanus, Lachesis Mutus |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Carnivora Research International |
| 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 - 12 [hp_X]/mL ARANEUS DIADEMATUS - 12 [hp_X]/mL ARSENIC TRIIODIDE - 8 [hp_X]/mL BAPTISIA TINCTORIA WHOLE - 3 [hp_X]/mL CAPSICUM - 6 [hp_X]/mL CARPINUS BETULUS FLOWERING TOP - 8 [hp_X]/mL CEANOTHUS AMERICANUS LEAF - 12 [hp_X]/mL CENTAURIUM ERYTHRAEA FLOWER - 8 [hp_X]/mL CUPRIC SULFATE - 6 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE - 3 [hp_X]/mL Load more... GALIUM APARINE WHOLE - 8 [hp_X]/mL LACHESIS MUTA VENOM - 12 [hp_X]/mL LARIX DECIDUA FLOWERING TOP - 8 [hp_X]/mL LEMON JUICE - 3 [hp_X]/mL LOBELIA INFLATA WHOLE - 4 [hp_X]/mL MANGANESE CHLORIDE - 6 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 4 [hp_X]/mL PINUS SYLVESTRIS LEAFY TWIG - 4 [hp_X]/mL POTASSIUM CHLORIDE - 6 [hp_X]/mL ROSA CANINA FRUIT - 8 [hp_X]/mL SCROPHULARIA NODOSA WHOLE - 8 [hp_X]/mL TEUCRIUM SCORODONIA FLOWERING TOP - 4 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG - 4 [hp_X]/mL ZINC GLUCONATE - 8 [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: | 06 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 14 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: | Carnivora Research International |
| 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 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 6T6CO7R3Z5 3029988O2T 5K1UO2888Y 00UK7646FG QOI241B01F 25B1Y14T8N B204P54Z1F LRX7AJ16DT VB06AV5US8 Load more... Z4B6561488 VSW71SS07I 9UMZ642257 AGN709ANTJ 9PP1T3TC5U QQE170PANO 2E32821G6I 11E6VI8VEG Q1RGP4UB73 660YQ98I10 3TNW8D08V3 7H443NUB2T LOK3I16O7G 1NT28V9397 U6WSN5SQ1Z |
| 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] |
| 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] |
| 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] |
| 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 Absorption Inhibitor [EPC] Decreased Copper Ion Absorption [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Magnetic Resonance Contrast Activity [MoA] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [EPC] Plant Proteins [CS] Potassium Compounds [CS] Potassium Salt [EPC] 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 |
|---|---|---|---|---|
| 69134-0002-1 | 60 mL in 1 BOTTLE, DROPPER (69134-0002-1) | 06 Sep, 2022 | 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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