| Drug NDC: | 17089-306 |
| 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: | Guna-dizzy |
| 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: | .alpha.-ketoglutaric Acid - Ambergris - Anamirta Cocculus Seed - Conium Maculatum Flowering Top - Epinephrine - Fumaric Acid - Malic Acid - Melatonin - Mineral Oil - Pteridium Aquilinum Root - Pyridoxine Hydrochloride - Quinhydrone - Quinine - Sus Scrofa Artery - Sus Scrofa Cerebellum - Sus Scrofa Placenta - Thiamine Hydrochloride - Tobacco Leaf - |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Guna Spa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Solution/ Drops |
| 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: | .ALPHA.-KETOGLUTARIC ACID - 6 [hp_X]/30mL AMBERGRIS - 6 [hp_X]/30mL ANAMIRTA COCCULUS SEED - 4 [hp_X]/30mL CONIUM MACULATUM FLOWERING TOP - 3 [hp_X]/30mL EPINEPHRINE - 6 [hp_X]/30mL FUMARIC ACID - 6 [hp_X]/30mL MALIC ACID - 6 [hp_X]/30mL MELATONIN - 4 [hp_C]/30mL MINERAL OIL - 8 [hp_X]/30mL PTERIDIUM AQUILINUM ROOT - 8 [hp_X]/30mL Load more... PYRIDOXINE HYDROCHLORIDE - 6 [hp_X]/30mL QUINHYDRONE - 6 [hp_X]/30mL QUININE SALICYLATE - 6 [hp_X]/30mL SUS SCROFA ARTERY - 6 [hp_X]/30mL SUS SCROFA CEREBELLUM - 6 [hp_X]/30mL SUS SCROFA PLACENTA - 6 [hp_X]/30mL THIAMINE HYDROCHLORIDE - 4 [hp_X]/30mL TOBACCO LEAF - 6 [hp_X]/30mL |
| 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: | 23 May, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 05 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: | Guna spa |
| 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. | |
| UPC: | 0317089306184 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 N0000185375 N0000175629 N0000184306 N0000185001 M0000728 M0016962 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 8ID597Z82X XTC0D02P6C 810258W28U Q28R5GF371 YKH834O4BH 88XHZ13131 817L1N4CKP JL5DK93RCL T5L8T28FGP HQJ5Z3SOIV Load more... 68Y4CF58BV P4A66LQ3QJ 6DY04L71DR 63O327782Q 49NGK53TPQ C8CV8867O8 M572600E5P 6YR2608RSU |
| 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 MOA: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] Catecholamine [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] Increased IgG Production [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: | Catecholamines [CS] Allergens [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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Allergens [CS] Analogs/Derivatives [Chemical/Ingredient] Antimalarial [EPC] Catecholamine [EPC] Catecholamines [CS] Cell-mediated Immunity [PE] Depigmenting Activity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Melanin Synthesis Inhibitor [EPC] Melanin Synthesis Inhibitors [MoA] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B6 Analog [EPC] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [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 |
|---|---|---|---|---|
| 17089-306-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-306-18) / 30 mL in 1 BOTTLE, DROPPER | 21 Dec, 2018 | 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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