| Drug NDC: | 43742-1646 |
| 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: | Tinitx |
| 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 Cepa, Argentum Nitricum, Chenopodium Anthelminticum, Dulcamara, Ginkgo Biloba, Chininum Sulphuricum, Cartilago Suis, Mucosa Nasalis Suis, Asarum Canadense, Onosmodium Virginianum, Natrum Salicylicum, Carbo Vegetabilis, Carboneum Sulphuratum, Cyclamen Europaeum, Gossypium Herbaceum, Graphites, Kreosotum, Phosphorus, Plumbum Metallicum, Theridion, Zincum Metallicum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Deseret Biologicals, 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 - 12 [hp_X]/mL ASARUM CANADENSE ROOT - 9 [hp_X]/mL CARBON DISULFIDE - 12 [hp_X]/mL CYCLAMEN PURPURASCENS TUBER - 12 [hp_X]/mL DYSPHANIA AMBROSIOIDES WHOLE - 6 [hp_X]/mL GINKGO - 6 [hp_X]/mL GOSSYPIUM HERBACEUM ROOT BARK - 12 [hp_X]/mL GRAPHITE - 12 [hp_X]/mL LEAD - 12 [hp_X]/mL ONION - 6 [hp_X]/mL Load more... ONOSMODIUM VIRGINIANUM - 10 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL QUININE SULFATE - 6 [hp_X]/mL SILVER NITRATE - 6 [hp_X]/mL SODIUM SALICYLATE - 10 [hp_X]/mL SOLANUM DULCAMARA TOP - 6 [hp_X]/mL SUS SCROFA CARTILAGE - 8 [hp_X]/mL SUS SCROFA NASAL MUCOSA - 8 [hp_X]/mL THERIDION CURASSAVICUM - 12 [hp_X]/mL WOOD CREOSOTE - 12 [hp_X]/mL ZINC - 12 [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: | 29 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 14 Oct, 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: | 03 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Deseret Biologicals, 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: | N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 E2O4O7TQYK S54S8B99E8 G728143D8Q 4H5RSU087I 19FUJ2C58T VQN1631P4C 4QQN74LH4O 2P299V784P 492225Q21H Load more... 604NK4250S 27YLU75U4W KF7Z0E0Q2B 95IT3W8JZE WIQ1H85SYP KPS1B1162N 73ECW5WG2F ID3Z1X61WY 9Z8D3HEM8L 3JYG22FD73 J41CSQ7QDS |
| 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] Antimalarial [EPC] 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 |
|---|---|---|---|---|
| 43742-1646-1 | 30 mL in 1 BOTTLE, DROPPER (43742-1646-1) | 29 May, 2020 | 14 Oct, 2025 | 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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