FDA.reportPublic FDA data

Belladonna Betula Formica

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:20

Label at a glance#

ProductBelladonna Betula Formica
Active ingredientBETULA PENDULA LEAF, ATROPA BELLADONNA, FORMICA RUFA
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 10 drops.
Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Betula e fol. (Silver Birch leaves) 3X, Atropa belladonna ex herba (Nightshade) 6X, Formica ex animale (Red wood ant) 6X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Potassium nitrate, Sodium hydroxide, Boric acid, Silver sulfate, Rose water

Prepared using rhythmical processes.

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. Do not use if safety seal is broken or missing.

REFRIGERATE AFTER OPENING. USE WITHIN 30 DAYS OF OPENING.
Opened on:_________________

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Belladonna Betula Formica Liquid 10mlBelladonna Betula Formica Liquid 10ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-2133-1Belladonna Betula Formica1 in 1 BAGLIQUID12
48951-2133-1Belladonna Betula Formica10 mL in 1 BOTTLE, DROPPERLIQUID102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2133BELLADONNA BETULA FORMICA LIQUID [URIEL PHARMACY INC.]2Legacy NDC, 2 package rows20241207_92aec9ba-4321-ecdd-e053-2995a90a6c23.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-213348951-2133-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER SULFATE8QG6HV4ZPOIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL8LGU7VM393IACT
BETULA PENDULA LEAF5HW39H9KDHACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
FORMICA RUFA55H0W83JO5ACTIB
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
BORIC ACIDR57ZHV85D4IACT
POTASSIUM NITRATERU45X2JN0ZIACT

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
2876bdfa-f933-876d-e063-6394a90aab5892aec9ba-4321-ecdd-e053-2995a90a6c232024-12-04WarningsExact identifier
spl id: 2876bdfa-f933-876d-e063-6394a90aab58
spl set id: 92aec9ba-4321-ecdd-e053-2995a90a6c23

Reported adverse events (FAERS/openFDA)#

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