| Drug NDC: | 17089-472 |
| 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 Sinus Plus |
| 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: | Althaea Officinalis Leaf - Calcium Sulfide - Copper - Drimia Maritima Bulb - Echinacea Angustifolia - Hydrastis Canadensis Whole - Lobaria Pulmonaria - Manganese - Mercuric Sulfide - Onion - Plantago Major Whole - Potassium Dichromate - Pulsatilla Vulgaris - Silicon Dioxide - Silver Nitrate - Sinusitisinum - Sus Scrofa Nasal Mucosa - |
| 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: | Spray |
| 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: | ALTHAEA OFFICINALIS LEAF - 2 [hp_X]/30mL ASCORBIC ACID - 3 [hp_X]/30mL CALCIUM SULFIDE - 6 [hp_X]/30mL COPPER - 8 [hp_X]/30mL DRIMIA MARITIMA BULB - 12 [hp_X]/30mL ECHINACEA ANGUSTIFOLIA - 3 [hp_X]/30mL HYDRASTIS CANADENSIS WHOLE - 6 [hp_X]/30mL LOBARIA PULMONARIA - 2 [hp_X]/30mL MANGANESE - 8 [hp_X]/30mL MERCURIC SULFIDE - 8 [hp_X]/30mL Load more... ONION - 6 [hp_X]/30mL PLANTAGO MAJOR WHOLE - 2 [hp_X]/30mL POTASSIUM DICHROMATE - 6 [hp_X]/30mL PULSATILLA VULGARIS - 6 [hp_X]/30mL SILICON DIOXIDE - 6 [hp_X]/30mL SILVER NITRATE - 10 [hp_X]/30mL SINUSITISINUM - 12 [hp_X]/30mL SUS SCROFA NASAL MUCOSA - 6 [hp_X]/30mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | NASAL |
| 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: | 17 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 15 Jun, 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: | 0317089472230 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000193618 M0001797 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | E2QQV92338 PQ6CK8PD0R 1MBW07J51Q 789U1901C5 3629601H5D VB06AV5US8 R763EBH88T D1YM0P5Z2T 42Z2K6ZL8P ZI0T668SF1 Load more... 492225Q21H W2469WNO6U T4423S18FM I76KB35JEV ETJ7Z6XBU4 95IT3W8JZE B575563DM5 ID3Z1X61WY |
| 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: | Vitamin C [EPC] Copper-containing Intrauterine Device [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: | Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [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: | Ascorbic Acid [CS] Copper [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] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Inhibit Ovum Fertilization [PE] Non-Standardized Food Allergenic Extract [EPC] Vegetable Proteins [CS] Vitamin C [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 |
|---|---|---|---|---|
| 17089-472-23 | 1 BOTTLE, SPRAY in 1 BOX (17089-472-23) / 30 mL in 1 BOTTLE, SPRAY | 17 Feb, 2021 | 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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