| Drug NDC: | 17089-298 |
| 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-kidney |
| 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: | Chondrodendron Tomentosum Root - Clerodendranthus Spicatus Leaf - Equisetum Hyemale - Escherichia Coli - Hieracium Pilosella Flowering Top - Methylene Blue - Nitric Acid - Ononis Campestris - Plantago Major - Pork Kidney - Potassium Nitrate - Proteus Vulgaris - Quinhydrone - Sarsaparilla - Solidago Virgaurea Flowering Top - Succinic Acid - Sus Scrofa Ureter - Sus Scrofa Urinary Bladder - |
| 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: | CHONDRODENDRON TOMENTOSUM ROOT - 2 [hp_X]/30mL CLERODENDRANTHUS SPICATUS LEAF - 2 [hp_X]/30mL EQUISETUM HYEMALE - 3 [hp_X]/30mL ESCHERICHIA COLI - 12 [hp_X]/30mL HIERACIUM PILOSELLA FLOWERING TOP - 1 [hp_X]/30mL METHYLENE BLUE - 8 [hp_X]/30mL NITRIC ACID - 12 [hp_X]/30mL ONONIS CAMPESTRIS - 2 [hp_X]/30mL PLANTAGO MAJOR - 2 [hp_X]/30mL PORK KIDNEY - 8 [hp_X]/30mL Load more... POTASSIUM NITRATE - 12 [hp_X]/30mL PROTEUS VULGARIS - 12 [hp_X]/30mL QUINHYDRONE - 8 [hp_X]/30mL SARSAPARILLA - 2 [hp_X]/30mL SOLIDAGO VIRGAUREA FLOWERING TOP - 1 [hp_X]/30mL SUCCINIC ACID - 6 [hp_X]/30mL SUS SCROFA URETER - 8 [hp_X]/30mL SUS SCROFA URINARY BLADDER - 8 [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: | 19 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: | 0317089298182 |
| UPC stands for Universal Product Code. | |
| UNII: | 395A3P448Z DSS8V86H3Y 59677RXH25 514B9K0L10 08A7Y81S1P T42P99266K 411VRN1TV4 RP8496915M W2469WNO6U X7BCI5P86H Load more... RU45X2JN0Z 11T9HCO30O P4A66LQ3QJ 2H1576D5WG 5405K23S50 AB6MNQ6J6L 7PGE2DJ8QM 3G7U72W8DA |
| 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: | Depigmenting Activity [PE] Melanin Synthesis Inhibitor [EPC] Melanin Synthesis Inhibitors [MoA] Oxidation-Reduction Activity [MoA] Oxidation-Reduction Agent [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 |
|---|---|---|---|---|
| 17089-298-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-298-18) / 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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