FDA.reportPublic FDA data

AllergEase

Manufacturer
Eight and Company L.L.C | King Bio Inc. | Apotheca Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:36:21

Label at a glance#

ProductAllergEase
Active ingredientONION, APIS MELLIFERA, ARALIA RACEMOSA ROOT, ARUNDO PLINIANA ROOT, BAPTISIA TINCTORIA ROOT, ECHINACEA, UNSPECIFIED, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, HISTAMINE DIHYDROCHLORIDE, LYCOPODIUM CLAVATUM SPORE, TOXICODENDRON PUBESCENS LEAF, SCHOENOCAULON OFFICINALE SEED, SANGUINARIA CANADENSIS ROOT, URTICA URENS WHOLE
Label structure10 sections

Dosage and administration

Adults and children over 12: 2 sprays into the mouth each 30 minutes as needed for symptom relief the first day. 2 sprays 3 times a day thereafter. Children under 12 consult a health care professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Allium cepa 6X, Apis mel 4X, Aralia rac 6X, Arundo 30C, Baptisia 4X, Echinacea 4X, Euphrasia 6X, Gelsemium 200C, Histaminum hydrochloricum 12X, Lycopodium 6X, Rhus Tox 200C, Sabadilla 6X, Sanguinaria 200C, Urtica Urens 4X, 200C.

PURPOSE:

OTC - PURPOSE SECTION

Temporarily relieves the symptoms of allergies and hay fever, including:

° runny nose
° itchy eyes
° rash
° headache and sneezing

WARNINGS:

WARNINGS SECTION

If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Keep box for indications and other warnings.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: 2 sprays into the mouth each 30 minutes as needed for symptom relief the first day. 2 sprays 3 times a day thereafter. Children under 12 consult a health care professional.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Do not use if the transparent seal around spray bottle is broken or missing.

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of allergies and hay fever, including:

° runny nose
° itchy eyes
° rash
° headache and sneezing
° natural

° gluten & lactose free

° no artifical flavors or colors

° no known negative side effects

° no known negative drug interactions

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Non-GMO glycerin, organic alcohol 20% v/v, purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

Mfd. for Eight and Company L.L.C.

Gaithersburg, MD 20879 1.800.377.5787

www.sprayology.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sprayology

AllergEase 

RELIEVES ALLERGY-RELATED DISCOMFORT

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

AllergEase LBLAllergEase LBL

AllergEase CNTAllergEase CNT

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130361096000313GTIN-13: 0361096000313
EAN-13: 0361096000313
GTIN-12: 361096000313
UPC-A: 361096000313
GTIN storage (14 digits): 00361096000313		ETCO0001 AllergEase CTN.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61096-1003-12023-12-14C16284748780-1ba0f9c33-5754-a910-e053-dadaa90a0b85AllergEase
61096-1003-12023-01-30C16284748780-1ba0f9c33-5754-a910-e053-dadaa90a0b85AllergEase
61096-1003-12021-02-11C16284748780-1ba0f9c33-5754-a910-e053-dadaa90a0b85AllergEase
61096-1003-12021-01-29C16284748780-1ba0f9c33-5754-a910-e053-dadaa90a0b85AllergEase

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-1003-1AllergEase41 mL in 1 BOTTLE, SPRAYLIQUID416
61096-1003-1AllergEase1 in 1 CARTONLIQUID16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
ARALIA RACEMOSA ROOTACTIVE INGREDIENTT90W4582DU1
ARUNDO PLINIANA ROOTACTIVE INGREDIENTZXE7LB03WC1
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU1
ECHINACEA, UNSPECIFIEDACTIVE INGREDIENT4N9P6CC1DX1
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644U1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
ONIONACTIVE INGREDIENT492225Q21H1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
SCHOENOCAULON OFFICINALE SEEDACTIVE INGREDIENT6NAF1689IO1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
ARALIA RACEMOSA ROOTACTIVE MOIETYT90W4582DU1
ARUNDO PLINIANA ROOTACTIVE MOIETYZXE7LB03WC1
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU1
ECHINACEA, UNSPECIFIEDACTIVE MOIETY4N9P6CC1DX1
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
HISTAMINEACTIVE MOIETY820484N8I31
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
ONIONACTIVE MOIETY492225Q21H1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
SCHOENOCAULON OFFICINALE SEEDACTIVE MOIETY6NAF1689IO1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61096-100361096-1003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARALIA RACEMOSA ROOTT90W4582DUACTIB
ARUNDO PLINIANA ROOTZXE7LB03WCACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
AllergEaseALLIUM CEPA, APIS MELLIFICA, ARALIA RAC, ARUNDO, BAPTISIA, ECHINACEA, EUPHRASIA, GELSEMIUM, HISTAMINUM, LYCOPODIUM, RHUS TOX, SABADILLA, SANGUINARIA, URTICA UR.Eight and Company L.L.Cec4fae96-ffe3-489c-9ed2-4aaec114c4932025-12-18WarningsExact identifier
ndc (package): 61096-1003-1
ndc (product): 61096-1003
ndc11 (package): 61096100301
spl id: 0e63d923-2818-4fd9-a3fb-a503cf2d963d
spl set id: ec4fae96-ffe3-489c-9ed2-4aaec114c493

Reported adverse events (FAERS/openFDA)#

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