FDA.reportPublic FDA data

Arnica Betula B

Manufacturer
Uriel Pharmacy Inc.
Effective date
2026-02-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:36:56

Label at a glance#

ProductArnica Betula B
Active ingredientBETULA PUBESCENS LEAF, BETULA PUBESCENS BARK, BOS TAURUS CEREBELLUM, BOS TAURUS BRAIN, BOS TAURUS PINEAL GLAND, SUS SCROFA EAR, BOS TAURUS NERVE, ARNICA MONTANA, LEAD, FORMICA RUFA, BIFENTHRIN, BOS TAURUS MESENCEPHALON, HONEY
Label structure9 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

INDICATIONS & USAGE SECTION

FOR ORAL USE ONLY

DOSAGE & ADMINISTRATION SECTION

Directions: Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow. Follow inside instructions to open ampule.

WARNINGS SECTION

Warnings:
NOT FOR INJECTION
Do not use if allergic to any ingredient. Consult a physician if symptoms worsen. If pregnant or nursing, consult a physician before use.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Betula e fol. (Silver birch leaves) 3X, Betula (cort.) dec. (Silver birch, bark dried) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quadrigemina (Bovine Quadrigeminal plate) 17X, Epiphysis (Bovine pineal body) 17X, Labyrinthus (Bovine inner ear) 17X, Medulla oblong. (ventr. quart.) (Bovine Myelencephalon ) 17X, Nervus statoacusticus (Bovine eighth cranial nerve) 17X, Arnica e pl. tota (Arnica) 30X, Onyx (Nat. Silicic acid with traces of iron oxide and carbon) 30X, Plumbum mellitum (Lead with honey) 30X, Formica ex animale 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

Prepared using rhythmical processes.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858 Made by Uriel, East Troy, WI 53120 shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Betula B AmpuleArnica Betula B Ampule

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1384-1Arnica Betula B10 in 1 BOXLIQUID106
48951-1384-1Arnica Betula B1 mL in 1 AMPULELIQUID16

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-138448951-1384-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
BETULA PUBESCENS LEAF84SOH0O3OOACTIB
BETULA PUBESCENS BARK3R504894L9ACTIB
BOS TAURUS CEREBELLUMQ09851U44FACTIB
BOS TAURUS BRAINA1YEE2DB8ZACTIB
BOS TAURUS PINEAL GLANDZ7RM5NBH36ACTIB
SUS SCROFA EAR7DX2J287CVACTIB
BOS TAURUS NERVE28G2U3MQJKACTIB
ARNICA MONTANAO80TY208ZWACTIB
LEAD2P299V784PACTIB
FORMICA RUFA55H0W83JO5ACTIB
BIFENTHRIN6B66JED0KNACTIB
BOS TAURUS MESENCEPHALONKCL8LW427JACTIB
HONEYY9H1V576FHACTIB

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
Arnica Betula BARNICA BETULA BUriel Pharmacy Inc.292c40ab-d670-9dc7-e063-6394a90a992a2026-02-02WarningsExact identifier
ndc (package): 48951-1384-1
ndc (product): 48951-1384
ndc11 (package): 48951138401
spl id: 49df13d2-5867-7d3a-e063-6394a90a1cc4
spl set id: 292c40ab-d670-9dc7-e063-6394a90a992a

Reported adverse events (FAERS/openFDA)#

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