| Drug NDC: | 55758-318 |
| 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: | Desintox |
| 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: | Antimonium Crudum,argentum Nitricum,cholesterinum, Robinia Pseudo-acacia,carbo Vegetabilis,cinchona,aesculus Hippocastanum,arnica Montana,berberis Vulgaris,ceanothus Americanus, Cynara Scolymus,equisetum Arvense,erigeron Canadensis,fucus Vesiculosus,ginkgo Biloba,hamamelis Virginiana,helonias Dioica,hydrastis Canadensis,hydrastis Canadensis,lappa Major,lespedeza Capitata,raphanus Sativus,taraxacum Officinale,viburnum Prunifolium,vitis Vinifera,ranunculus Bulbosus |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Pharmadel Llc |
| 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 - 9 [hp_X]/60mL ANTIMONY TRISULFIDE - 10 [hp_X]/60mL ARCTIUM LAPPA ROOT - 6 [hp_X]/60mL ARNICA MONTANA - 6 [hp_X]/60mL BERBERIS VULGARIS ROOT BARK - 6 [hp_X]/60mL CEANOTHUS AMERICANUS LEAF - 6 [hp_X]/60mL CHAMAELIRIUM LUTEUM ROOT - 6 [hp_X]/60mL CINCHONA BARK - 8 [hp_X]/60mL CYNARA SCOLYMUS LEAF - 6 [hp_X]/60mL EQUISETUM ARVENSE TOP - 6 [hp_X]/60mL Load more... ERIGERON CANADENSIS - 6 [hp_X]/60mL FUCUS VESICULOSUS - 6 [hp_X]/60mL GINKGO - 10 [hp_X]/60mL GOLDENSEAL - 6 [hp_X]/60mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 6 [hp_X]/60mL HORSE CHESTNUT - 6 [hp_X]/60mL LESPEDEZA CAPITATA FLOWERING TOP - 6 [hp_X]/60mL RADISH - 6 [hp_X]/60mL RANUNCULUS BULBOSUS - 4 [hp_X]/60mL ROBINIA PSEUDOACACIA BARK - 10 [hp_X]/60mL SILVER NITRATE - 10 [hp_X]/60mL TARAXACUM OFFICINALE - 6 [hp_X]/60mL VIBURNUM PRUNIFOLIUM BARK - 6 [hp_X]/60mL VITIS VINIFERA WHOLE - 6 [hp_X]/60mL |
| 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 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: | Pharmadel LLC |
| 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: | N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 F79059A38U 597E9BI3Z3 O80TY208ZW 1TH8Q20J0U 25B1Y14T8N DQV54Y5H3U 292E43P4I9 B71UA545DE 1DP6Y6B65Z Load more... 16D08B0B9N 535G2ABX9M 19FUJ2C58T ZW3Z11D0JV T7S323PKJS 3C18L6RJAZ F930LFZ4LF EM5RP35463 AEQ8NXJ0MB 7TPC058OWY 95IT3W8JZE 39981FM375 J411UTU0HN 22E66I250J |
| 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 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] 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] Dietary Proteins [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [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 |
|---|---|---|---|---|
| 55758-318-02 | 1 BOTTLE in 1 BOX (55758-318-02) / 60 mL in 1 BOTTLE | 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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