FDA.reportPublic FDA data

ECHINACEA, UNSPECIFIED

Manufacturer
Uriel Pharmacy Inc.
Effective date
2020-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:01

Label at a glance#

ProductArnica comp.
Active ingredientECHINACEA, UNSPECIFIED, BAPTISIA AUSTRALIS ROOT, SOLANUM DULCAMARA FLOWER, SOLANUM NIGRUM FRUIT, MERCURIALIS PERENNIS, ARNICA MONTANA, SOLANUM LYCOPERSICUM FRUITING TOP, APIS MELLIFERA, EUCALYPTUS GUM, COLCHICUM AUTUMNALE WHOLE, BRYONIA ALBA ROOT, EUPATORIUM CANNABINUM FLOWERING TOP, BENZOIC ACID, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Arnica 4X, Echinacea (Purple coneflower) 4X, Mercurialis (Dog’s mercury) 4X, Solanum lycopersicum (Tomato) 4X, Apis (Honeybee) 5X, Baptisia (Wild indigo) 5X, Bryonia (White bryony) 5X, Colchicum (Meadow saffron) 5X, Eucalyptus 5X, Eupatorium (Hemp agrimony) 5X, Solanum dulcamara (Bittersweet nightshade) 5X, Acidum benzoicum (Benzoic acid) 6X, Rhus tox. (Sumac) 7X, Solanum nigrum (Black nightshade) 8X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
www.urielpharmacy.com

Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica comp.Arnica comp.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1339-1Arnica comp.1 mL in 1 AMPULELIQUID11
48951-1339-1Arnica comp.10 in 1 BOXLIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1339ARNICA COMP. LIQUID [URIEL PHARMACY INC.]1Legacy NDC, 2 package rows20201218_b6acddc9-b4f3-4b25-e053-2995a90a175e.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-133948951-1339-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
SODIUM CHLORIDE451W47IQ8XIACT
BAPTISIA AUSTRALIS ROOT7S944UTF9RACTIB
SOLANUM DULCAMARA FLOWERW6J1279A6KACTIB
SOLANUM NIGRUM FRUITXA101YYV55ACTIB
MERCURIALIS PERENNISQ35465A1MAACTIB
ARNICA MONTANAO80TY208ZWACTIB
SOLANUM LYCOPERSICUM FRUITING TOPX636CG4BH0ACTIB
APIS MELLIFERA7S82P3R43ZACTIB
EUCALYPTUS GUM72T9EZC2VXACTIB
COLCHICUM AUTUMNALE WHOLEW79255C628ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EUPATORIUM CANNABINUM FLOWERING TOPA5296YC7FSACTIB
BENZOIC ACID8SKN0B0MIMACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
WATER059QF0KO0RIACT

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
b6acddc9-b4f4-4b25-e053-2995a90a175eb6acddc9-b4f3-4b25-e053-2995a90a175e2020-12-17WarningsExact identifier
spl id: b6acddc9-b4f4-4b25-e053-2995a90a175e
spl set id: b6acddc9-b4f3-4b25-e053-2995a90a175e

Reported adverse events (FAERS/openFDA)#

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