| Drug NDC: | 17089-350 |
| 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-awareness |
| 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: | Betaine - Bufo Bufo Cutaneous Gland - Calcium Carbonate - Chromic Sulfate - Cicuta Virosa Root - Copper - Folic Acid - Gold - Cobalamin - Iron - Lachesis Muta Venom - Melatonin - Molybdenum - Neurotrophin-3 - Neurotrophin-4 - Oxytocin - Silicon Dioxide - Sus Scrofa Frontal Lobe - Sus Scrofa Temporal Lobe - Thyrotropin Alfa - Ubidecarenone - Vanadium - Zinc - Brain-derived Neurotrophic Factor Human - |
| 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: | BETAINE - 3 [hp_X]/30mL BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - 4 [hp_C]/30mL BUFO BUFO CUTANEOUS GLAND - 12 [hp_X]/30mL CALCIUM CARBONATE - 3 [hp_X]/30mL CHROMIC SULFATE - 3 [hp_X]/30mL CICUTA VIROSA ROOT - 12 [hp_X]/30mL COBALAMIN - 3 [hp_X]/30mL COPPER - 12 [hp_X]/30mL FOLIC ACID - 3 [hp_X]/30mL GOLD - 12 [hp_X]/30mL Load more... IRON - 3 [hp_X]/30mL LACHESIS MUTA VENOM - 12 [hp_X]/30mL MELATONIN - 4 [hp_C]/30mL MOLYBDENUM - 3 [hp_X]/30mL NEUROTROPHIN-3 - 4 [hp_C]/30mL NEUROTROPHIN-4 - 4 [hp_C]/30mL OXYTOCIN - 6 [hp_X]/30mL SILICON DIOXIDE - 12 [hp_X]/30mL SUS SCROFA FRONTAL LOBE - 6 [hp_X]/30mL SUS SCROFA TEMPORAL LOBE - 6 [hp_X]/30mL THYROTROPIN ALFA - 3 [hp_X]/30mL UBIDECARENONE - 3 [hp_X]/30mL VANADIUM - 6 [hp_X]/30mL ZINC - 3 [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: | 16 Apr, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 09 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: | 0317089350187 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000175804 N0000175805 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185508 N0000175629 N0000184306 M0000728 N0000009705 N0000175828 M0015703 N0000175949 M0021496 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 3SCV180C9W A1ED6W905I Q59QU6N72Q H0G9379FGK Y0C99N5TMZ YEA9P21S8N 8406EY2OQA 789U1901C5 935E97BOY8 79Y1949PYO Load more... E1UOL152H7 VSW71SS07I JL5DK93RCL 81AH48963U 02R4V6T25Y P658DCA9XD 1JQS135EYN ETJ7Z6XBU4 GV54Q19G55 490XI1KB4S AVX3D5A4LM EJ27X76M46 00J9J9XKDE 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 MOA: | Methylating Activity [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: | Methylating Agent [EPC] Copper-containing Intrauterine Device [EPC] Standardized Chemical Allergen [EPC] Oxytocic [EPC] Thyroid Stimulating Hormone [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] Increased Uterine Smooth Muscle Contraction or Tone [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] Oxytocin [CS] Thyrotropin [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] Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Increased Coagulation Factor Activity [PE] Increased Histamine Release [PE] Increased Uterine Smooth Muscle Contraction or Tone [PE] Inhibit Ovum Fertilization [PE] Methylating Activity [MoA] Methylating Agent [EPC] Oxytocic [EPC] Oxytocin [CS] Standardized Chemical Allergen [EPC] Thyroid Stimulating Hormone [EPC] Thyrotropin [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 |
|---|---|---|---|---|
| 17089-350-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-350-18) / 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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