FDA.reportPublic FDA data

Arnica Betula A

Manufacturer
Uriel Pharmacy Inc.
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:24:31

Label at a glance#

ProductArnica Betula A
Active ingredientBETULA PENDULA LEAF, BOS TAURUS NERVE, ARNICA MONTANA FLOWER, SILICON DIOXIDE, HONEY, FORMICA RUFA, LEAD, BOS TAURUS CEREBELLUM, BOS TAURUS PITUITARY GLAND, C12-17 ALKANE, BOS TAURUS EYE, SUS SCROFA THALAMUS, BETULA PUBESCENS BARK, BOS TAURUS BRAIN
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: Betula (Silver birch leaves) 3X,Betula (cort.) decoct. (Silver birch, bark dried) 4X,Cerebellum (Bovine cerebellum) 17X,Corpora quad. (Bovine Quadrigeminal plate) 17X,Hypophysis (Bovine pituitary gland) 17X,Iris - bovis (Bovine iris) 17X,Medulla oblong. (Bovine Myelencephalon) 17X,Nervus opticus (Bovine second cranial nerve) 17X,Retina et chor. (Bovine retina and choroid) 17X,Thalamus (Bovine thalamus) 17X,Arnica 30X,Chrysolith (Silicate of magnesium and iron) 30X,Formica (Red ant) 30X,Mel (Honey) 30X,Plumbum met.(Lead) 30X

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
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Betula A AmpulesArnica Betula A Ampules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1352-1Arnica Betula A10 in 1 BOXLIQUID102
48951-1352-1Arnica Betula A1 mL in 1 AMPULELIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1352ARNICA BETULA A LIQUID [URIEL PHARMACY INC.]2Legacy NDC, 2 package rows20231115_ca02ff85-b505-634f-e053-2995a90a222a.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
48951-135248951-1352-1

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
BETULA PENDULA LEAF5HW39H9KDHACTIB
BOS TAURUS NERVE28G2U3MQJKACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
HONEYY9H1V576FHACTIB
FORMICA RUFA55H0W83JO5ACTIB
LEAD2P299V784PACTIB
BOS TAURUS CEREBELLUMQ09851U44FACTIB
BOS TAURUS PITUITARY GLAND7JM57I419KACTIB
C12-17 ALKANEFW7807707BACTIB
BOS TAURUS EYEVTW461N43PACTIB
SUS SCROFA THALAMUS3D6Q7UV74JACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
BETULA PUBESCENS BARK3R504894L9ACTIB
BOS TAURUS BRAINA1YEE2DB8ZACTIB

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
0a2151ce-82f2-629a-e063-6394a90a7e1bca02ff85-b505-634f-e053-2995a90a222a2023-11-14WarningsExact identifier
spl id: 0a2151ce-82f2-629a-e063-6394a90a7e1b
spl set id: ca02ff85-b505-634f-e053-2995a90a222a

Reported adverse events (FAERS/openFDA)#

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