| Drug NDC: | 43857-0515 |
| 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: | Oligo Bio Iodine |
| 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: | Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Hypophysis Suis, Thyroidinum (suis), Cysteinum, Manganese Gluconate, Alpha-ketoglutaricum Acidum, Calcarea Carbonica, Ferrum Iodatum, Fumaricum Acidum, Kali Iodatum, Natrum Oxalaceticum, Pulsatilla (vulgaris), Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Bioactive Nutritional, 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 - 12 [hp_X]/mL CHELIDONIUM MAJUS - 3 [hp_X]/mL COPPER - 12 [hp_X]/mL CYSTEINE - 9 [hp_X]/mL EUGENOL - 12 [hp_X]/mL FERROUS IODIDE - 12 [hp_X]/mL FORMALDEHYDE - 12 [hp_X]/mL FUCUS VESICULOSUS - 6 [hp_X]/mL FUMARIC ACID - 12 [hp_X]/mL GERMANIUM SESQUIOXIDE - 8 [hp_X]/mL Load more... GINKGO - 6 [hp_X]/mL GOLD - 12 [hp_X]/mL HUMAN COXSACKIEVIRUS A2 - 33 [hp_C]/mL HUMAN COXSACKIEVIRUS A7 - 33 [hp_C]/mL HUMAN COXSACKIEVIRUS B1 - 33 [hp_C]/mL HUMAN COXSACKIEVIRUS B3 - 33 [hp_C]/mL HUMAN COXSACKIEVIRUS B4 - 33 [hp_C]/mL IODINE - 4 [hp_X]/mL LIDOCAINE - 12 [hp_X]/mL LYCOPUS VIRGINICUS - 4 [hp_X]/mL MANGANESE GLUCONATE - 10 [hp_X]/mL MERCURIUS SOLUBILIS - 12 [hp_X]/mL MOLYBDENUM - 12 [hp_X]/mL MUMPS VIRUS - 30 [hp_X]/mL NICKEL - 12 [hp_X]/mL OXOGLURIC ACID - 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/mL PALLADIUM - 12 [hp_X]/mL PINUS SYLVESTRIS LEAFY TWIG - 6 [hp_X]/mL POTASSIUM IODIDE - 12 [hp_X]/mL RUBELLA VIRUS - 12 [hp_X]/mL SILVER - 12 [hp_X]/mL SODIUM DIETHYL OXALACETATE - 12 [hp_X]/mL SPONGIA OFFICINALIS SKELETON, ROASTED - 3 [hp_X]/mL SUS SCROFA PITUITARY GLAND - 8 [hp_X]/mL SUS SCROFA THYROID - 8 [hp_X]/mL TIN - 12 [hp_X]/mL TITANIUM - 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: | 27 Jun, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 06 Nov, 2024 |
| 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: | 23 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | BioActive Nutritional, 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: | M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185508 N0000175629 N0000184306 M0000728 N0000175682 M0000897 N0000175426 N0000175976 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | I76KB35JEV 7E889U5RNN 789U1901C5 K848JZ4886 3T8H1794QW F5452U54PN 1HG84L3525 535G2ABX9M 88XHZ13131 96WE91N25T Load more... 19FUJ2C58T 79Y1949PYO 82KK5J435E P3026TK92O ADL68M27WD 69O1DAO10G FYF75V7FDY 9679TC07X4 98PI200987 TWH5125Q6F 9YY2F980SV 324Y4038G2 81AH48963U YF0S03R447 7OV03QG267 8ID597Z82X 2E32821G6I 5TWQ1V240M Q1RGP4UB73 1C4QK22F9J U751HEX436 3M4G523W1G 6CA025Y4FG 1PIP394IID L0PFEMQ1DT 6RV024OAUQ 387GMG9FH5 D1JT611TNE 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: | Copper-containing Intrauterine Device [EPC] Standardized Chemical Allergen [EPC] Amide Local Anesthetic [EPC] Antiarrhythmic [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: | Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [PE] Increased Histamine Release [PE] Cell-mediated Immunity [PE] Local Anesthesia [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: | Copper [CS] Allergens [CS] Amides [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] Amide Local Anesthetic [EPC] Amides [CS] Antiarrhythmic [EPC] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Increased Histamine Release [PE] Inhibit Ovum Fertilization [PE] Local Anesthesia [PE] Magnetic Resonance Contrast Activity [MoA] Paramagnetic Contrast Agent [EPC] 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 |
|---|---|---|---|---|
| 43857-0515-1 | 60 mL in 1 BOTTLE, DROPPER (43857-0515-1) | 27 Jun, 2019 | 06 Nov, 2024 | 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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