| Drug NDC: | 58809-207 |
| 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: | Texaclear Homeopathic Allergy Relief Kids Cedar Fever |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Texaclear Homeopathic Allergy Relief |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | Kids Cedar Fever |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| 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: | Over 100 Extracts |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Gm Pharmaceuticals, Inc |
| 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: | ACACIA POLLEN - 30 [hp_X]/mL ACER NEGUNDO POLLEN - 30 [hp_X]/mL ACER RUBRUM POLLEN - 30 [hp_X]/mL ACER SACCHARINUM POLLEN - 30 [hp_X]/mL ACER SACCHARUM POLLEN - 30 [hp_X]/mL AGROSTIS GIGANTEA POLLEN - 30 [hp_X]/mL ALLENROLFEA OCCIDENTALIS POLLEN - 30 [hp_X]/mL ALNUS RHOMBIFOLIA POLLEN - 30 [hp_X]/mL AMARANTHUS HYBRIDUS POLLEN - 30 [hp_X]/mL AMARANTHUS PALMERI POLLEN - 30 [hp_X]/mL Load more... AMARANTHUS RETROFLEXUS POLLEN - 30 [hp_X]/mL AMARANTHUS SPINOSUS POLLEN - 30 [hp_X]/mL AMARANTHUS TUBERCULATUS POLLEN - 30 [hp_X]/mL AMBROSIA ACANTHICARPA POLLEN - 30 [hp_X]/mL AMBROSIA BIDENTATA POLLEN - 30 [hp_X]/mL AMBROSIA CONFERTIFLORA POLLEN - 30 [hp_X]/mL AMBROSIA DUMOSA POLLEN - 30 [hp_X]/mL AMBROSIA PSILOSTACHYA POLLEN - 30 [hp_X]/mL AMBROSIA TRIFIDA POLLEN - 30 [hp_X]/mL ARTEMISIA ANNUA POLLEN - 30 [hp_X]/mL ARTEMISIA TRIDENTATA POLLEN - 30 [hp_X]/mL ARTEMISIA VULGARIS WHOLE - 30 [hp_X]/mL ATRIPLEX CANESCENS POLLEN - 30 [hp_X]/mL BACCHARIS HALIMIFOLIA WHOLE - 30 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 6 [hp_X]/mL BASSIA SCOPARIA POLLEN - 30 [hp_X]/mL BETULA LENTA POLLEN - 30 [hp_X]/mL BETULA OCCIDENTALIS WHOLE - 30 [hp_X]/mL BROMUS INERMIS POLLEN - 30 [hp_X]/mL BROUSSONETIA PAPYRIFERA POLLEN - 30 [hp_X]/mL CARYA CORDIFORMIS WHOLE - 30 [hp_X]/mL CARYA GLABRA POLLEN - 30 [hp_X]/mL CARYA ILLINOINENSIS POLLEN - 30 [hp_X]/mL CARYA LACINIOSA POLLEN - 30 [hp_X]/mL CARYA OVATA POLLEN - 30 [hp_X]/mL CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/mL CUPRESSUS ARIZONICA POLLEN - 30 [hp_X]/mL CYCLACHAENA XANTHIFOLIA POLLEN - 30 [hp_X]/mL DACTYLIS GLOMERATA POLLEN - 30 [hp_X]/mL DISTICHLIS SPICATA POLLEN - 30 [hp_X]/mL ECHINACEA, UNSPECIFIED - 6 [hp_X]/mL ELYMUS REPENS POLLEN - 30 [hp_X]/mL FAGUS GRANDIFOLIA POLLEN - 30 [hp_X]/mL FESTUCA PRATENSIS POLLEN - 30 [hp_X]/mL FRAXINUS AMERICANA POLLEN - 30 [hp_X]/mL FRAXINUS PENNSYLVANICA POLLEN - 30 [hp_X]/mL FRAXINUS VELUTINA POLLEN - 30 [hp_X]/mL GUTIERREZIA SAROTHRAE WHOLE - 30 [hp_X]/mL HYDRASTIS CANADENSIS WHOLE - 6 [hp_X]/mL IVA ANNUA POLLEN - 30 [hp_X]/mL JUGLANS NIGRA POLLEN - 30 [hp_X]/mL JUNIPER BERRY - 30 [hp_X]/mL JUNIPERUS DEPPEANA WHOLE - 30 [hp_X]/mL JUNIPERUS OSTEOSPERMA POLLEN - 30 [hp_X]/mL JUNIPERUS SCOPULORUM POLLEN - 30 [hp_X]/mL JUNIPERUS VIRGINIANA POLLEN - 30 [hp_X]/mL LIGUSTRUM LUCIDUM WHOLE - 30 [hp_X]/mL LIQUIDAMBAR STYRACIFLUA POLLEN - 30 [hp_X]/mL LOLIUM MULTIFLORUM POLLEN - 30 [hp_X]/mL LOLIUM PERENNE POLLEN - 30 [hp_X]/mL MELALEUCA QUINQUENERVIA POLLEN - 30 [hp_X]/mL MORUS ALBA WHOLE - 30 [hp_X]/mL MORUS RUBRA POLLEN - 30 [hp_X]/mL MYRRH - 6 [hp_X]/mL PASCOPYRUM SMITHII POLLEN - 30 [hp_X]/mL PHALARIS ARUNDINACEA POLLEN - 30 [hp_X]/mL PHLEUM PRATENSE POLLEN - 30 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 6 [hp_X]/mL PINUS PONDEROSA POLLEN - 30 [hp_X]/mL PINUS STROBUS POLLEN - 30 [hp_X]/mL PINUS TAEDA POLLEN - 30 [hp_X]/mL PLANTAGO LANCEOLATA POLLEN - 30 [hp_X]/mL PLATANUS OCCIDENTALIS POLLEN - 30 [hp_X]/mL POPULUS ALBA POLLEN - 30 [hp_X]/mL POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN - 30 [hp_X]/mL POPULUS FREMONTII POLLEN - 30 [hp_X]/mL POPULUS NIGRA POLLEN - 30 [hp_X]/mL QUERCUS ALBA WHOLE - 30 [hp_X]/mL QUERCUS GAMBELII POLLEN - 30 [hp_X]/mL QUERCUS MACROCARPA POLLEN - 30 [hp_X]/mL QUERCUS NIGRA POLLEN - 30 [hp_X]/mL QUERCUS RUBRA BARK - 30 [hp_X]/mL QUERCUS STELLATA POLLEN - 30 [hp_X]/mL QUERCUS VELUTINA WHOLE - 30 [hp_X]/mL RUMEX ACETOSELLA POLLEN - 30 [hp_X]/mL RUMEX CRISPUS POLLEN - 30 [hp_X]/mL SALSOLA KALI WHOLE - 30 [hp_X]/mL SECALE CEREALE POLLEN - 30 [hp_X]/mL SOLIDAGO CANADENSIS WHOLE - 30 [hp_X]/mL SORGHUM HALEPENSE POLLEN - 30 [hp_X]/mL TAXODIUM DISTICHUM POLLEN - 30 [hp_X]/mL THUJA OCCIDENTALIS LEAF - 30 [hp_X]/mL THUJA PLICATA LEAF - 30 [hp_X]/mL TRIADICA SEBIFERA WHOLE - 30 [hp_X]/mL TRITICUM AESTIVUM POLLEN - 30 [hp_X]/mL ULMUS AMERICANA POLLEN - 30 [hp_X]/mL ULMUS CRASSIFOLIA POLLEN - 30 [hp_X]/mL ULMUS PUMILA POLLEN - 30 [hp_X]/mL URTICA DIOICA POLLEN - 30 [hp_X]/mL XANTHIUM STRUMARIUM POLLEN - 30 [hp_X]/mL ZEA MAYS POLLEN - 30 [hp_X]/mL |
| 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: | 21 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 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: | GM Pharmaceuticals, INC |
| 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: | 0358809207305 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185367 N0000175629 N0000184306 N0000185001 M0017130 M0000728 N0000185006 N0000185371 N0000185375 M0006342 M0016962 M0008672 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 43DDR2YDYZ P6K070AR8V 700NK45C76 95447163DG V38QUQ7861 HU8V6E7HOA 5W6JAI84OI 7X8HL8GRTM EK7F0414PI 1GH3WV23KH Load more... 73B14PX5FW 380W4HYR6N 92N6W6KO2G U2AI3H2J5Y M3S672G75O 63TBJ590BL ZIO18VN6HJ RX18M46K8L KU1V1898XX 36R82U4DL6 YI19RB8YFD JDR81QW9ZQ 26U0BU8G83 2CV09XA44X 5EF0HWI5WU 07A108ZKW5 JQ5HI5004M NPA6EIU3QB 766QT72BK6 51I6N3XIML MP18902J3H KPO1Z9N98A PYO4JR720Y 5BGG872373 54UN9R2798 098LKX5NCN 232DMH0XVF V80TPZ0T6J 83N78IDA7P GOA51670YV 4N9P6CC1DX ON2T85TA2O 34X886W1H4 A0WFQ8P6N1 G684LX721Q 2WZG2G15WX LJT6I6Z8FD 4Y008TDX2F R763EBH88T Y2U5S5PF22 1BV28146ZR O84B5194RL 7XR372977U 15L060HV8H 0G82TT8ZFY PY0JA16R2G 8AA7186XEP 5Q246DS5BS VJI0WKK736 4T81LB52R0 NX974IRT8E C4228R0MX2 9LYI4RTZ52 JC71GJ1F3L 6AU0ZD8T1O FAY1Y90VJ9 65M88RW2EG 11E6VI8VEG 042SUA2DS9 TX1ER5UV3T 4O1FFR8ARN DO87T1U2CI E03U1K03LK VU8C8SB23P 476DVV63WP 426RHB4302 0MGE63QPFJ 8160EU25B5 9HC15X34LX 57BTU4547U 6U600U1326 X26K8566JX W34X0P8636 3NQP837A96 N52MIQ81ZW V825XJG64G 0BKP293XE9 I6KAZ8AO1O OLL328076K 577VA5B4HP O12H03B41R 0T0DQN8786 R9I752FESH 9166K7Q8MX F1KAH8374D 89BAT511BD G82398SD3I 030R993R8E DNB59M1NVU 2QOF601J1M 74PD8J616H |
| 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: | Non-Standardized Pollen Allergenic Extract [EPC] Standardized Pollen Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [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: | Pollen [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Food Additives [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] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 58809-207-30 | 30 mL in 1 BOTTLE, DROPPER (58809-207-30) | 21 Aug, 2020 | 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. | ||||
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.