FDA.reportPublic FDA data

TexaClear Texas Allergy Relief plus Cedar Fever

Product NDC
58809-214
11-digit product format
588090214
Labeler code
58809
Product ID
58809-214_45871b50-d2fa-68c5-e063-6394a90aa1e8
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
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
Active 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 [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

Additional Listing Data#

Finished product
Yes
Brand name base
TexaClear Texas Allergy Relief plus Cedar Fever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
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
HOLCUS LANATUS POLLEN6 [hp_X]/mL
MORUS RUBRA POLLEN6 [hp_X]/mL
PINUS STROBUS POLLEN6 [hp_X]/mL
NASTURTIUM OFFICINALE6 [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 POLLEN5 [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 POLLEN5 [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 POLLEN5 [hp_X]/mL
MYRRH6 [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
GOLDENSEAL6 [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 POLLEN5 [hp_X]/mL
AMARANTHUS TUBERCULATUS POLLEN6 [hp_X]/mL
CARYA ILLINOINENSIS POLLEN6 [hp_X]/mL
LIQUIDAMBAR STYRACIFLUA POLLEN5 [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 ROOT6 [hp_X]/mL
ACER SACCHARUM POLLEN6 [hp_X]/mL
ANTHOXANTHUM ODORATUM POLLEN6 [hp_X]/mL
AVENA SATIVA POLLEN6 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/mL
BAPTISIA TINCTORIA ROOT6 [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
QUERCUS GAMBELII POLLEN5 [hp_X]/mL
POPULUS NIGRA POLLEN6 [hp_X]/mL
QUERCUS ALBA POLLEN6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 5 · 85 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DO87T1U2CIInternal UNII lookup
6EIJ3D04MRInternal UNII lookup
8KDG09A4GOInternal UNII lookup
89BAT511BDInternal UNII lookup
M3S672G75OInternal UNII lookup
07A108ZKW5Internal UNII lookup
93963RFO1PInternal UNII lookup
GOA51670YVInternal UNII lookup
B67NF86HF0Internal UNII lookup
70O1TP6H01Internal UNII lookup
9LYI4RTZ52Internal UNII lookup
TX1ER5UV3TInternal UNII lookup
YH89GMV676Internal UNII lookup
380W4HYR6NInternal UNII lookup
G684LX721QInternal UNII lookup
1BV28146ZRInternal UNII lookup
PY0JA16R2GInternal UNII lookup
E03U1K03LKInternal UNII lookup
476DVV63WPInternal UNII lookup
5928LJ1441Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a5d6aa5-e998-e028-e063-6294a90afde6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-214-01TexaClear Texas Allergy Relief plus Cedar Fever30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
58809-214-02TexaClear Texas Allergy Relief plus Cedar Fever60 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS602
58809-214-04TexaClear Texas Allergy Relief plus Cedar Fever118 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-214TEXACLEAR 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) SOLUTION/ DROPS [GM PHARMACEUTICALS, INC]1Current NDC, 3 package rows20231118_0a5d6aa5-e998-e028-e063-6294a90afde6.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 Texas Allergy Relief plus Cedar FeverANTIGENS ALL ZONES GRASSES TREES AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENSGM Pharmaceuticals, INC0a5d6aa5-e998-e028-e063-6294a90afde62025-12-09WarningsExact identifier
ndc (product): 58809-214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58809-214-015880902140130 mL in 1 BOTTLE, DROPPER (58809-214-01) 30 ml2023-11-10NoNoCurrent
58809-214-025880902140260 mL in 1 BOTTLE, DROPPER (58809-214-02) 60 ml2023-11-10NoNoCurrent
58809-214-0458809021404118 mL in 1 BOTTLE, DROPPER (58809-214-04) 118 ml2023-11-10NoNoCurrent