FDA.reportPublic FDA data

TexaClear All Season Allergy Relief

Product NDC
58809-213
11-digit product format
588090213
Labeler code
58809
Product ID
58809-213_4586b1ca-b20e-f78a-e063-6394a90a2523
Type
HUMAN OTC DRUG
Nonproprietary name
Antigens All Zones Grasses Trees and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
GM Pharmaceuticals, INC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-11-10
Substance
HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS GAMBELII POLLEN; PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN
Active strength
6; 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; 5; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 5; 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; 6 [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
Pharmacologic 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],...
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TexaClear All Season Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOLCUS LANATUS POLLEN6 [hp_X]/mL
MORUS RUBRA POLLEN6 [hp_X]/mL
PINUS STROBUS POLLEN6 [hp_X]/mL
NASTURTIUM OFFICINALE5 [hp_X]/mL
AMARANTHUS SPINOSUS POLLEN6 [hp_X]/mL
FRAXINUS AMERICANA POLLEN6 [hp_X]/mL
JUGLANS NIGRA POLLEN6 [hp_X]/mL
JUNIPERUS VIRGINIANA POLLEN6 [hp_X]/mL
PLATANUS OCCIDENTALIS POLLEN6 [hp_X]/mL
POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN6 [hp_X]/mL
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN6 [hp_X]/mL
QUERCUS RUBRA POLLEN6 [hp_X]/mL
SORGHUM HALEPENSE POLLEN6 [hp_X]/mL
TRITICUM AESTIVUM POLLEN6 [hp_X]/mL
URTICA DIOICA POLLEN6 [hp_X]/mL
AMBROSIA PSILOSTACHYA POLLEN6 [hp_X]/mL
RUMEX CRISPUS POLLEN6 [hp_X]/mL
SECALE CEREALE POLLEN6 [hp_X]/mL
TAXODIUM DISTICHUM POLLEN6 [hp_X]/mL
XANTHIUM STRUMARIUM POLLEN6 [hp_X]/mL
QUERCUS NIGRA POLLEN6 [hp_X]/mL
QUERCUS STELLATA POLLEN6 [hp_X]/mL
SOLIDAGO CANADENSIS POLLEN6 [hp_X]/mL
AMARANTHUS RETROFLEXUS POLLEN6 [hp_X]/mL
AMBROSIA CONFERTIFLORA POLLEN6 [hp_X]/mL
EUCALYPTUS GLOBULUS POLLEN6 [hp_X]/mL
MYRRH5 [hp_X]/mL
SALSOLA KALI POLLEN6 [hp_X]/mL
QUERCUS MACROCARPA POLLEN6 [hp_X]/mL
SYAGRUS ROMANZOFFIANA POLLEN6 [hp_X]/mL
ZEA MAYS POLLEN6 [hp_X]/mL
CHENOPODIUM ALBUM POLLEN6 [hp_X]/mL
ARTEMISIA TRIDENTATA POLLEN6 [hp_X]/mL
GOLDENSEAL5 [hp_X]/mL
FAGUS GRANDIFOLIA POLLEN6 [hp_X]/mL
FRAXINUS VELUTINA POLLEN6 [hp_X]/mL
BROUSSONETIA PAPYRIFERA POLLEN6 [hp_X]/mL
PINUS ECHINATA POLLEN6 [hp_X]/mL
URTICA URENS WHOLE5 [hp_X]/mL
AMARANTHUS PALMERI POLLEN6 [hp_X]/mL
AMARANTHUS TUBERCULATUS POLLEN6 [hp_X]/mL
CARYA ILLINOINENSIS POLLEN6 [hp_X]/mL
LIQUIDAMBAR STYRACIFLUA POLLEN6 [hp_X]/mL
MELALEUCA QUINQUENERVIA POLLEN6 [hp_X]/mL
MORUS ALBA POLLEN6 [hp_X]/mL
HESPEROCYPARIS ARIZONICA POLLEN6 [hp_X]/mL
JUNIPERUS OCCIDENTALIS POLLEN6 [hp_X]/mL
OLEA EUROPAEA POLLEN6 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA ROOT5 [hp_X]/mL
ACER SACCHARUM POLLEN6 [hp_X]/mL
ANTHOXANTHUM ODORATUM POLLEN6 [hp_X]/mL
AVENA SATIVA POLLEN6 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT5 [hp_X]/mL
BAPTISIA TINCTORIA ROOT5 [hp_X]/mL
ACER NEGUNDO POLLEN6 [hp_X]/mL
AMBROSIA ACANTHICARPA POLLEN6 [hp_X]/mL
AMBROSIA ARTEMISIIFOLIA POLLEN6 [hp_X]/mL
AMBROSIA TRIFIDA POLLEN6 [hp_X]/mL
ARTEMISIA VULGARIS POLLEN6 [hp_X]/mL
CARYA OVATA POLLEN6 [hp_X]/mL
CELTIS OCCIDENTALIS POLLEN6 [hp_X]/mL
CYCLACHAENA XANTHIFOLIA POLLEN6 [hp_X]/mL
JUNIPERUS ASHEI POLLEN6 [hp_X]/mL
LIGUSTRUM VULGARE POLLEN6 [hp_X]/mL
MYRICA CERIFERA POLLEN6 [hp_X]/mL
POA PRATENSIS POLLEN6 [hp_X]/mL
POPULUS ALBA POLLEN6 [hp_X]/mL
RUMEX ACETOSELLA POLLEN6 [hp_X]/mL
SALIX NIGRA POLLEN6 [hp_X]/mL
SCHINUS MOLLE POLLEN6 [hp_X]/mL
ACACIA DEALBATA POLLEN6 [hp_X]/mL
ATRIPLEX WRIGHTII POLLEN6 [hp_X]/mL
PASPALUM NOTATUM POLLEN6 [hp_X]/mL
POPULUS NIGRA POLLEN6 [hp_X]/mL
QUERCUS ALBA POLLEN6 [hp_X]/mL
QUERCUS GAMBELII POLLEN6 [hp_X]/mL
PLANTAGO LANCEOLATA POLLEN6 [hp_X]/mL
PROSOPIS JULIFLORA POLLEN6 [hp_X]/mL
QUERCUS VIRGINIANA POLLEN6 [hp_X]/mL
ULMUS AMERICANA POLLEN6 [hp_X]/mL
AMBROSIA BIDENTATA POLLEN6 [hp_X]/mL
BASSIA SCOPARIA POLLEN6 [hp_X]/mL
BETULA NIGRA POLLEN6 [hp_X]/mL
DISTICHLIS SPICATA POLLEN6 [hp_X]/mL
EUPATORIUM CAPILLIFOLIUM POLLEN6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 2 of 5 · 85 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6U600U1326Internal UNII lookup
W34X0P8636Internal UNII lookup
644CZ16IR5Internal UNII lookup
73B14PX5FWInternal UNII lookup
63TBJ590BLInternal UNII lookup
7XW7TB10X9Internal UNII lookup
JC71GJ1F3LInternal UNII lookup
2MH135KC6GInternal UNII lookup
57BTU4547UInternal UNII lookup
84ZOM591BBInternal UNII lookup
74PD8J616HInternal UNII lookup
098LKX5NCNInternal UNII lookup
YI19RB8YFDInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
34X886W1H4Internal UNII lookup
LJT6I6Z8FDInternal UNII lookup
51I6N3XIMLInternal UNII lookup
96LRW14765Internal UNII lookup
IHN2NQ5OF9Internal UNII lookup
1GH3WV23KHInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
065d16e7-87f4-ecaa-e063-6294a90abca7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-213-01TexaClear All Season Allergy Relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS303
58809-213-02TexaClear All Season Allergy Relief60 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-213TEXACLEAR ALL SEASON ALLERGY RELIEF (ANTIGENS ALL ZONES GRASSES TREES AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENS) SOLUTION/ DROPS [GM PHARMACEUTICALS, INC]2Current NDC, 2 package rows20231117_065d16e7-87f4-ecaa-e063-6294a90abca7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TexaClear All Season Allergy ReliefANTIGENS ALL ZONES GRASSES TREES AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENSGM Pharmaceuticals, INC065d16e7-87f4-ecaa-e063-6294a90abca72025-12-09WarningsExact identifier
ndc (product): 58809-213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58809-213-015880902130130 mL in 1 BOTTLE, DROPPER (58809-213-01) 30 ml2023-11-10NoNoCurrent
58809-213-025880902130260 mL in 1 BOTTLE, DROPPER (58809-213-02) 60 ml2023-11-10NoNoCurrent