58809-213 NDC - TEXACLEAR ALL SEASON ALLERGY RELIEF (ANTIGENS ALL ZONES GRASSES TREES AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENS)

Drug Information

Product NDC: 58809-213

Proprietary Name: TexaClear All Season Allergy Relief

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


Administration Route(s): SUBLINGUAL

Dosage Form(s): SOLUTION/ DROPS

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
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  • Allergens [CS];
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  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
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  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
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  • Allergens [CS];
  • Cell-mediated Immunity [PE];
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  • Cell-mediated Immunity [PE];
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  • Cell-mediated Immunity [PE];
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  • Cell-mediated Immunity [PE];
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  • 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]

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
158809-213-0260 mL in 1 BOTTLE, DROPPER (58809-213-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC58809-213The 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 NAMEHUMAN OTC DRUGIndicates 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 NAMETexaClear All Season Allergy ReliefThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAntigens All Zones Grasses Trees and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urensThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBLINGUALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/10/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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 NAMEGM Pharmaceuticals, INCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACACIA 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 POLLENAn 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 STRENGTH6; 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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [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: 12/13/2023