58809-215 NDC - TEXACLEAR TEXAS ALLERGY RELIEF PLUS CEDAR FEVER (ANTIGENS ALL ZONES GRASSES, TREES, AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENS)

Drug Information

Product NDC: 58809-215

Proprietary Name: TexaClear Texas Allergy Relief plus Cedar Fever

Non Proprietary Name: Antigens All Zones Grasses, Trees, and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens

Active Ingredient(s):

6 [hp_X]/min ACACIA DEALBATA POLLEN;
6 [hp_X]/min ACER NEGUNDO POLLEN;
6 [hp_X]/min ACER SACCHARUM POLLEN;
6 [hp_X]/min AMARANTHUS PALMERI POLLEN;
6 [hp_X]/min AMARANTHUS RETROFLEXUS POLLEN;
6 [hp_X]/min AMARANTHUS SPINOSUS POLLEN;
6 [hp_X]/min AMARANTHUS TUBERCULATUS POLLEN;
6 [hp_X]/min AMBROSIA ACANTHICARPA POLLEN;
6 [hp_X]/min AMBROSIA ARTEMISIIFOLIA POLLEN;
6 [hp_X]/min AMBROSIA BIDENTATA POLLEN;
6 [hp_X]/min AMBROSIA CONFERTIFLORA POLLEN;
6 [hp_X]/min AMBROSIA PSILOSTACHYA POLLEN;
6 [hp_X]/min AMBROSIA TRIFIDA POLLEN;
6 [hp_X]/min ANTHOXANTHUM ODORATUM POLLEN;
6 [hp_X]/min ARTEMISIA TRIDENTATA POLLEN;
6 [hp_X]/min ARTEMISIA VULGARIS POLLEN;
6 [hp_X]/min ATRIPLEX WRIGHTII POLLEN;
6 [hp_X]/min AVENA SATIVA POLLEN;
5 [hp_X]/min BAPTISIA TINCTORIA ROOT;
6 [hp_X]/min BASSIA SCOPARIA POLLEN;
6 [hp_X]/min BETULA NIGRA POLLEN;
6 [hp_X]/min BROUSSONETIA PAPYRIFERA POLLEN;
6 [hp_X]/min CARYA ILLINOINENSIS POLLEN;
6 [hp_X]/min CARYA OVATA POLLEN;
6 [hp_X]/min CELTIS OCCIDENTALIS POLLEN;
6 [hp_X]/min CHENOPODIUM ALBUM POLLEN;
6 [hp_X]/min CYCLACHAENA XANTHIFOLIA POLLEN;
6 [hp_X]/min DISTICHLIS SPICATA POLLEN;
5 [hp_X]/min ECHINACEA ANGUSTIFOLIA ROOT;
6 [hp_X]/min EUCALYPTUS GLOBULUS POLLEN;
6 [hp_X]/min EUPATORIUM CAPILLIFOLIUM POLLEN;
6 [hp_X]/min FAGUS GRANDIFOLIA POLLEN;
6 [hp_X]/min FRAXINUS AMERICANA POLLEN;
6 [hp_X]/min FRAXINUS VELUTINA POLLEN;
5 [hp_X]/min GOLDENSEAL;
6 [hp_X]/min HESPEROCYPARIS ARIZONICA POLLEN;
6 [hp_X]/min HOLCUS LANATUS POLLEN;
6 [hp_X]/min JUGLANS NIGRA POLLEN;
6 [hp_X]/min JUNIPERUS ASHEI POLLEN;
6 [hp_X]/min JUNIPERUS OCCIDENTALIS POLLEN;
6 [hp_X]/min JUNIPERUS VIRGINIANA POLLEN;
6 [hp_X]/min LIGUSTRUM VULGARE POLLEN;
6 [hp_X]/min LIQUIDAMBAR STYRACIFLUA POLLEN;
6 [hp_X]/min MELALEUCA QUINQUENERVIA POLLEN;
6 [hp_X]/min MORUS ALBA POLLEN;
6 [hp_X]/min MORUS RUBRA POLLEN;
6 [hp_X]/min MYRICA CERIFERA POLLEN;
5 [hp_X]/min MYRRH;
5 [hp_X]/min NASTURTIUM OFFICINALE;
6 [hp_X]/min OLEA EUROPAEA POLLEN;
6 [hp_X]/min PASPALUM NOTATUM POLLEN;
5 [hp_X]/min PHYTOLACCA AMERICANA ROOT;
6 [hp_X]/min PINUS ECHINATA POLLEN;
6 [hp_X]/min PINUS STROBUS POLLEN;
6 [hp_X]/min PLANTAGO LANCEOLATA POLLEN;
6 [hp_X]/min PLATANUS OCCIDENTALIS POLLEN;
6 [hp_X]/min POA PRATENSIS POLLEN;
6 [hp_X]/min POPULUS ALBA POLLEN;
6 [hp_X]/min POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN;
6 [hp_X]/min POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN;
6 [hp_X]/min POPULUS NIGRA POLLEN;
6 [hp_X]/min PROSOPIS JULIFLORA POLLEN;
6 [hp_X]/min QUERCUS ALBA POLLEN;
6 [hp_X]/min QUERCUS GAMBELII POLLEN;
6 [hp_X]/min QUERCUS MACROCARPA POLLEN;
6 [hp_X]/min QUERCUS NIGRA POLLEN;
6 [hp_X]/min QUERCUS RUBRA POLLEN;
6 [hp_X]/min QUERCUS STELLATA POLLEN;
6 [hp_X]/min QUERCUS VIRGINIANA POLLEN;
6 [hp_X]/min RUMEX ACETOSELLA POLLEN;
6 [hp_X]/min RUMEX CRISPUS POLLEN;
6 [hp_X]/min SALIX NIGRA POLLEN;
6 [hp_X]/min SALSOLA KALI POLLEN;
6 [hp_X]/min SCHINUS MOLLE POLLEN;
6 [hp_X]/min SECALE CEREALE POLLEN;
6 [hp_X]/min SOLIDAGO CANADENSIS POLLEN;
6 [hp_X]/min SORGHUM HALEPENSE POLLEN;
6 [hp_X]/min SYAGRUS ROMANZOFFIANA POLLEN;
6 [hp_X]/min TAXODIUM DISTICHUM POLLEN;
6 [hp_X]/min TRITICUM AESTIVUM POLLEN;
6 [hp_X]/min ULMUS AMERICANA POLLEN;
6 [hp_X]/min URTICA DIOICA POLLEN;
5 [hp_X]/min URTICA URENS WHOLE;
6 [hp_X]/min XANTHIUM STRUMARIUM POLLEN;
6 [hp_X]/min ZEA MAYS POLLEN

Administration Route(s): ORAL

Dosage Form(s): TABLET, CHEWABLE

Pharmacy Class(es):

Allergens [CS];
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Allergens [CS];
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Allergens [CS];
Cell-mediated Immunity [PE];
Cell-mediated Immunity [PE];
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Cell-mediated Immunity [PE];
Cell-mediated Immunity [PE];
Cell-mediated Immunity [PE];
Cell-mediated Immunity [PE];
Cell-mediated Immunity [PE];
Cell-mediated Immunity [PE];
Cell-mediated Immunity [PE];
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Cell-mediated Immunity [PE];
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Cell-mediated Immunity [PE];
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Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE];
Increased Histamine Release [PE]

Labeler Information

Labeler Name:	GM Pharmaceuticals, INC
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	11/10/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	58809-215-90	90 min in 1 BOTTLE (58809-215-90)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	58809-215	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.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	TexaClear Texas Allergy Relief plus Cedar Fever	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Antigens All Zones Grasses, Trees, and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET, CHEWABLE	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	11/10/2023	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product types are broken down into several potential Marketing Categories, such as NDA/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.
LABELER NAME	GM Pharmaceuticals, INC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACACIA DEALBATA POLLEN; ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX WRIGHTII POLLEN; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; EUCALYPTUS GLOBULUS POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; HESPEROCYPARIS ARIZONICA POLLEN; HOLCUS LANATUS POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRICA CERIFERA POLLEN; MYRRH; NASTURTIUM OFFICINALE; OLEA EUROPAEA POLLEN; PASPALUM NOTATUM POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS ECHINATA POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI POLLEN; SCHINUS MOLLE POLLEN; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; TAXODIUM DISTICHUM POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN; URTICA URENS WHOLE; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 5; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6
ACTIVE INGRED UNIT	[hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min
PHARM CLASSES	Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]

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This page was last updated on: 4/12/2024

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