FDA.reportPublic FDA data

Allergena

Manufacturer
Meditrend, Inc. DBA Progena Professional Formulations
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:29:55

Label at a glance#

ProductAllergena Zone 4
Active ingredientSORGHUM BICOLOR POLLEN, SORGHUM X DRUMMONDII POLLEN, PHLEUM PRATENSE POLLEN, TRITICUM AESTIVUM POLLEN, PASCOPYRUM SMITHII POLLEN, ECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, GOLDENSEAL, MYRRH, NASTURTIUM OFFICINALE, PHYTOLACCA AMERICANA ROOT, FENUGREEK LEAF, ACACIA POLLEN, FRAXINUS AMERICANA POLLEN, ALNUS INCANA SUBSP. RUGOSA POLLEN, FRAXINUS VELUTINA POLLEN, FRAXINUS PENNSYLVANICA POLLEN, FAGUS GRANDIFOLIA POLLEN, BETULA PAPYRIFERA POLLEN, BETULA NIGRA POLLEN, BETULA LENTA POLLEN, ACER NEGUNDO POLLEN, JUNIPERUS VIRGINIANA POLLEN, POPULUS DELTOIDES POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, ULMUS AMERICANA POLLEN, ULMUS PUMILA POLLEN, ULMUS CRASSIFOLIA POLLEN, BACCHARIS HALIMIFOLIA POLLEN, CELTIS OCCIDENTALIS POLLEN, CARYA CORDIFORMIS POLLEN, CARYA GLABRA POLLEN, CARYA OVATA POLLEN, CARYA ALBA POLLEN, JUNIPERUS ASHEI POLLEN, LIGUSTRUM VULGARE POLLEN, ACER RUBRUM POLLEN, ACER SACCHARINUM POLLEN, PROSOPIS JULIFLORA POLLEN, BROUSSONETIA PAPYRIFERA POLLEN, MORUS RUBRA POLLEN, MORUS ALBA POLLEN, QUERCUS VELUTINA POLLEN, QUERCUS MACROCARPA POLLEN, QUERCUS STELLATA POLLEN, QUERCUS RUBRA POLLEN, QUERCUS ALBA POLLEN, CARYA ILLINOINENSIS POLLEN, POPULUS NIGRA POLLEN, PINUS NIGRA POLLEN, PINUS TAEDA POLLEN, PINUS SYLVESTRIS POLLEN, POPULUS ALBA POLLEN, PICEA PUNGENS POLLEN, LIQUIDAMBAR STYRACIFLUA POLLEN, PLATANUS OCCIDENTALIS POLLEN, AILANTHUS ALTISSIMA POLLEN, JUGLANS NIGRA POLLEN, SALIX NIGRA POLLEN, AMPHIACHYRIS DRACUNCULOIDES POLLEN, AMARANTHUS PALMERI POLLEN, XANTHIUM STRUMARIUM POLLEN, RUMEX CRISPUS POLLEN, BASSIA SCOPARIA POLLEN, SOLIDAGO CANADENSIS POLLEN, CHENOPODIUM ALBUM POLLEN, CYCLACHAENA XANTHIFOLIA POLLEN, IVA ANNUA POLLEN, IVA ANGUSTIFOLIA POLLEN, CHENOPODIUM AMBROSIOIDES POLLEN, ARTEMISIA VULGARIS POLLEN, URTICA DIOICA POLLEN, AMARANTHUS RETROFLEXUS POLLEN, AMARANTHUS SPINOSUS POLLEN, PLANTAGO LANCEOLATA POLLEN, AMBROSIA TRIFIDA POLLEN, AMBROSIA ARTEMISIIFOLIA POLLEN, AMBROSIA PSILOSTACHYA POLLEN, SALSOLA TRAGUS POLLEN, ARTEMISIA TRIDENTATA POLLEN, ARTEMISIA FRIGIDA POLLEN, RUMEX OBTUSIFOLIUS POLLEN, AMARANTHUS TUBERCULATUS POLLEN, ATRIPLEX CANESCENS POLLEN, ARTEMISIA ANNUA POLLEN, CYNODON DACTYLON POLLEN, POA ANNUA POLLEN, BROMUS INERMIS POLLEN, ZEA MAYS POLLEN, SORGHUM HALEPENSE POLLEN, KOELERIA MACRANTHA POLLEN, FESTUCA PRATENSIS POLLEN, ARRHENATHERUM ELATIUS POLLEN, AVENA SATIVA POLLEN, DACTYLIS GLOMERATA POLLEN, ELYMUS REPENS POLLEN, AGROSTIS GIGANTEA POLLEN, PHALARIS ARUNDINACEA POLLEN, LOLIUM MULTIFLORUM POLLEN, LOLIUM PERENNE POLLEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Antigens 6X, 12X, 30X **Zone 4 Grasses, **Zone 4 Trees, **Zone 4 Weeds; Herbal Drainage Remedies 3X:Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum; Echinacea 3X HPUS

OTC - PURPOSE SECTION

Purpose:Relief from Sneezing, Runny Nose, Itchy Eyes and Sinus Congestion.*

INDICATIONS & USAGE SECTION

Use:This product is a homeopathic dilution formulated to support the body's immunity for the temporary relief of allergies.*

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children. In case of overdose, get
medical help or contact a Poison Control Center right away.

WARNINGS SECTION

Warnings:

  • Use Only as directed.
  • Stop use and ask a doctor ifsymptoms worsen or do not
    improve after 5 days.
  • If pregnant or breast-feeding, consult a health professional
    before use.

DOSAGE & ADMINISTRATION SECTION

Directions:•Shake Well Before Use.• Adults (12 and Older)
10-15 drops under the tongue three times daily.• Children
(Under 12) 6 drops under the tongue three times daily or as
directed by your health care professional. • Consult a Physician
for use in children under 12 years of age.

OTHER SAFETY INFORMATION

Other Information: Do not use if TAMPER EVIDENT seal
around neck of bottle is missing or broken.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:USP Purified Water and 25% USP Ethanol.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62713-958-01AllergenaZone 430 mL in 1 BOTTLE, DROPPERLIQUID304
62713-958-02AllergenaZone 459 mL in 1 BOTTLE, DROPPERLIQUID594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62713-958ALLERGENA ZONE 4 (ECHINACEA,BAPTISIA TINCTORIA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, ZONE 4 TREE, ZONE 4 WEED, ZONE 4 GRASS) LIQUID [MEDITREND, INC. DBA PROGENA PROFESSIONAL FORMULATIONS]4Current NDC, Legacy NDC, 2 package rows20250101_da8c2ba0-ec94-4b3e-86e8-787be2e79391.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 3 · 106 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62713-95862713-958-01, 62713-958-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 104 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORGHUM BICOLOR POLLENLD795V73G4ACTIB
SORGHUM X DRUMMONDII POLLENB43R30VP73ACTIB
PHLEUM PRATENSE POLLEN65M88RW2EGACTIB
TRITICUM AESTIVUM POLLENF1KAH8374DACTIB
PASCOPYRUM SMITHII POLLEN6AU0ZD8T1OACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
GOLDENSEALZW3Z11D0JVACTIB
MYRRHJC71GJ1F3LACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
FENUGREEK LEAF487RI96K8ZACTIB
ACACIA POLLEN43DDR2YDYZACTIB
FRAXINUS AMERICANA POLLENG684LX721QACTIB
ALNUS INCANA SUBSP. RUGOSA POLLEN605T96G8Y5ACTIB
FRAXINUS VELUTINA POLLENLJT6I6Z8FDACTIB
FRAXINUS PENNSYLVANICA POLLEN2WZG2G15WXACTIB
FAGUS GRANDIFOLIA POLLEN34X886W1H4ACTIB
BETULA PAPYRIFERA POLLEN3538FNV8AYACTIB
BETULA NIGRA POLLEN93963RFO1PACTIB
BETULA LENTA POLLENJQ5HI5004MACTIB
ACER NEGUNDO POLLENP6K070AR8VACTIB
JUNIPERUS VIRGINIANA POLLENPY0JA16R2GACTIB
POPULUS DELTOIDES POLLEN476DVV63WPACTIB
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN5928LJ1441ACTIB
CUPRESSUS ARIZONICA POLLEN232DMH0XVFACTIB
TAXODIUM DISTICHUM POLLENO12H03B41RACTIB
ULMUS AMERICANA POLLEN89BAT511BDACTIB
ULMUS PUMILA POLLEN030R993R8EACTIB
ULMUS CRASSIFOLIA POLLENG82398SD3IACTIB
BACCHARIS HALIMIFOLIA POLLENBBO1IJ3ZIWACTIB
CELTIS OCCIDENTALIS POLLEN68R9X9Y96XACTIB
CARYA CORDIFORMIS POLLENO99P60FU6GACTIB
CARYA GLABRA POLLENKPO1Z9N98AACTIB
CARYA OVATA POLLEN54UN9R2798ACTIB
CARYA ALBA POLLENG2A764T54BACTIB
JUNIPERUS ASHEI POLLEN544F8MEY0YACTIB
LIGUSTRUM VULGARE POLLENY3FRX92Z0EACTIB

Source Document#

Source XML

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
Allergena Zone 4ECHINACEA,BAPTISIA TINCTORIA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, ZONE 4 TREE, ZONE 4 WEED, ZONE 4 GRASSMeditrend, Inc. DBA Progena Professional Formulationsda8c2ba0-ec94-4b3e-86e8-787be2e793912024-12-31WarningsExact identifier
ndc (package): 62713-958-01
ndc (package): 62713-958-02
ndc (product): 62713-958
ndc11 (package): 62713095802
ndc11 (package): 62713095801
spl id: 2a96f37d-03c3-678c-e063-6394a90ae0c6
spl set id: da8c2ba0-ec94-4b3e-86e8-787be2e79391

Reported adverse events (FAERS/openFDA)#

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