FDA.reportPublic FDA data

Allergena

Manufacturer
Meditrend, Inc. DBA Progena Professional Formulations
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:54

Label at a glance#

ProductAllergena Zone 4 Kids
Active ingredientARTEMISIA 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, AGROSTIS GIGANTEA POLLEN, AVENA SATIVA POLLEN, DACTYLIS GLOMERATA POLLEN, ELYMUS REPENS POLLEN, PHALARIS ARUNDINACEA POLLEN, LOLIUM MULTIFLORUM POLLEN, LOLIUM PERENNE POLLEN, SORGHUM 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, ALNUS INCANA SUBSP. RUGOSA POLLEN, FRAXINUS VELUTINA POLLEN, FRAXINUS PENNSYLVANICA POLLEN, FRAXINUS AMERICANA 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, PINUS NIGRA POLLEN, PINUS TAEDA POLLEN, PINUS SYLVESTRIS POLLEN, POPULUS NIGRA 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
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 if symptoms worsen or do not improve after 5 days.
  • If Pregnant or breastfeeding, 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 (2-12) 6-10 drops under the tongue three times daily. • Infants (0-2) 3-6 drops under the tongue three time daily or as directed by your health care professional.

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 Vegetable Glycerin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*www.allergena.com/drugdisclaimer

**Standard antigen mix used in this product is cross-reactive with Zone 4 tree, weed and grass allergens.  For a complete list of allergens visit www.allergena.com

Manufactured for Progena Professional Formulations
4820 Eubank Blvd. NE, ABQ, NM 87111, www.progena.com

image of label
image of label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62713-959-01AllergenaZone 4 Kids30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62713-959ALLERGENA ZONE 4 KIDS (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]2Current NDC, Legacy NDC, 1 package rows20250101_3d18b5d4-da59-42d6-a44d-0bf7bf914a86.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
62713-95962713-959-01

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
ARTEMISIA TRIDENTATA POLLENYI19RB8YFDACTIB
ARTEMISIA FRIGIDA POLLEN5AN5LR8L3FACTIB
RUMEX OBTUSIFOLIUS POLLENR6H8O3GVL9ACTIB
AMARANTHUS TUBERCULATUS POLLEN92N6W6KO2GACTIB
ATRIPLEX CANESCENS POLLEN26U0BU8G83ACTIB
ARTEMISIA ANNUA POLLEN36R82U4DL6ACTIB
CYNODON DACTYLON POLLEN175F461W10ACTIB
POA ANNUA POLLEN7U437HHU5CACTIB
BROMUS INERMIS POLLEN766QT72BK6ACTIB
ZEA MAYS POLLEN74PD8J616HACTIB
SORGHUM HALEPENSE POLLEN577VA5B4HPACTIB
KOELERIA MACRANTHA POLLENIIC6H3WF6JACTIB
FESTUCA PRATENSIS POLLENA0WFQ8P6N1ACTIB
ARRHENATHERUM ELATIUS POLLENB55BD1QM4QACTIB
AGROSTIS GIGANTEA POLLENHU8V6E7HOAACTIB
AVENA SATIVA POLLENA7IKY24TR7ACTIB
DACTYLIS GLOMERATA POLLEN83N78IDA7PACTIB
ELYMUS REPENS POLLENON2T85TA2OACTIB
PHALARIS ARUNDINACEA POLLENFAY1Y90VJ9ACTIB
LOLIUM MULTIFLORUM POLLENVJI0WKK736ACTIB
LOLIUM PERENNE POLLEN4T81LB52R0ACTIB
SORGHUM BICOLOR POLLENLD795V73G4ACTIB
SORGHUM X DRUMMONDII POLLENB43R30VP73ACTIB
PHLEUM PRATENSE POLLEN65M88RW2EGACTIB
TRITICUM AESTIVUM POLLENF1KAH8374DACTIB
PASCOPYRUM SMITHII POLLEN6AU0ZD8T1OACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
GOLDENSEALZW3Z11D0JVACTIB
MYRRHJC71GJ1F3LACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
FENUGREEK LEAF487RI96K8ZACTIB
ACACIA POLLEN43DDR2YDYZACTIB
ALNUS INCANA SUBSP. RUGOSA POLLEN605T96G8Y5ACTIB
FRAXINUS VELUTINA POLLENLJT6I6Z8FDACTIB
FRAXINUS PENNSYLVANICA POLLEN2WZG2G15WXACTIB
FRAXINUS AMERICANA POLLENG684LX721QACTIB

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 4 KidsECHINACEA, 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 Formulations3d18b5d4-da59-42d6-a44d-0bf7bf914a862024-12-31WarningsExact identifier
ndc (package): 62713-959-01
ndc (product): 62713-959
ndc11 (package): 62713095901
spl id: 2a96b135-ba7d-6bfd-e063-6294a90a6fa1
spl set id: 3d18b5d4-da59-42d6-a44d-0bf7bf914a86

Reported adverse events (FAERS/openFDA)#

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