| Drug NDC: | 17089-311 |
| 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-liver |
| 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: | Ceanothus Americanus Leaf - Chelidonium Majus - Chionanthus Virginicus Bark - Choline Hydroxide - Cobalamin - Culver Root - Fumaric Acid - Inositol - Lycopodium Clavatum Spore - Niacin - Pork Liver - Potassium Sulfate - Pyridoxine Hydrochloride - Riboflavin - Silybum Marianum Seed - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Sodium Sulfate - Sus Scrofa Gall Bladder - Sus Scrofa Jejunum - Sus Scrofa Pancreas - Sus Scrofa Spleen - Taraxacum Officinale - Thiamine Hydrochloride - |
| 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: | Pellet |
| 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: | CEANOTHUS AMERICANUS LEAF - 6 [hp_X]/4g CHELIDONIUM MAJUS - 2 [hp_X]/4g CHIONANTHUS VIRGINICUS BARK - 6 [hp_X]/4g CHOLINE HYDROXIDE - 4 [hp_X]/4g COBALAMIN - 4 [hp_X]/4g CULVER'S ROOT - 6 [hp_X]/4g FUMARIC ACID - 4 [hp_X]/4g INOSITOL - 4 [hp_X]/4g LYCOPODIUM CLAVATUM SPORE - 6 [hp_X]/4g NIACIN - 6 [hp_X]/4g Load more... PORK LIVER - 6 [hp_X]/4g POTASSIUM SULFATE - 12 [hp_X]/4g PYRIDOXINE HYDROCHLORIDE - 6 [hp_X]/4g RIBOFLAVIN - 6 [hp_X]/4g SILYBUM MARIANUM SEED - 2 [hp_X]/4g SODIUM DIETHYL OXALACETATE - 4 [hp_X]/4g SODIUM PYRUVATE - 4 [hp_X]/4g SODIUM SULFATE - 8 [hp_X]/4g SUS SCROFA GALLBLADDER - 8 [hp_X]/4g SUS SCROFA JEJUNUM - 8 [hp_X]/4g SUS SCROFA PANCREAS - 8 [hp_X]/4g SUS SCROFA SPLEEN - 8 [hp_X]/4g TARAXACUM OFFICINALE - 2 [hp_X]/4g THIAMINE HYDROCHLORIDE - 6 [hp_X]/4g |
| 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: | 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. | |
| NUI: | N0000175594 M0014839 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 25B1Y14T8N 7E889U5RNN 7THJ3EG9SY 8406EY2OQA M2O62YTN42 88XHZ13131 4L6452S749 C88X29Y479 2679MF687A 6EC706HI7F Load more... 1K573LC5TV 68Y4CF58BV TLM2976OFR U946SH95EE 6CA025Y4FG POD38AIF08 0YPR65R21J B6A98VOI9I TA501QD69R 9Y3J3362RY 92AMN5J79Y 39981FM375 M572600E5P |
| 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: | Nicotinic Acid [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 CS: | Nicotinic Acids [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: | Analogs/Derivatives [Chemical/Ingredient] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Nicotinic Acid [EPC] Nicotinic Acids [CS] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC] Vitamin B 6 [Chemical/Ingredient] Vitamin B6 Analog [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 |
|---|---|---|---|---|
| 17089-311-20 | 2 TUBE in 1 BOX (17089-311-20) / 4 g in 1 TUBE | 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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