FDA.reportPublic FDA data

Helleborus comp. B

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:29:40

Label at a glance#

ProductHelleborus comp. B
Active ingredientCOLCHICUM AUTUMNALE WHOLE, FORMICA RUFA, BOS TAURUS SPLEEN, ANTIMONY, SILVER, HELLEBORUS FOETIDUS ROOT, EQUISETUM ARVENSE TOP, PHOSPHORUS, LEAD
Label structure8 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: Colchicum (Meadow saffron) 4X, Helleborus (Christmas rose) 4X, Lien (Bovine spleen) 8X, Argentum (Silver) 12X, Stibium (Antimony) 17X, Equisetum (Common horsetail) 20X, Formica (Red wood ant) 20X, Phosphorus (Yellow phosphorus) 30X, Plumbum (Lead) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

Prepared using rhythmical processes.

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

Helleborus comp. B AmpulesHelleborus comp. B Ampules

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-5115-12026-01-29C16284748780-149896155-ac38-586f-e063-e6dba90add90Helleborus comp. B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5115-1Helleborus comp. B1 mL in 1 AMPULELIQUID14
48951-5115-1Helleborus comp. B10 in 1 BOXLIQUID104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5115HELLEBORUS COMP. B LIQUID [URIEL PHARMACY INC.]4Legacy NDC, 2 package rows20241219_8f5f2a82-0928-8238-e053-2a95a90a26f0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-511548951-5115-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
COLCHICUM AUTUMNALE WHOLEW79255C628ACTIB
FORMICA RUFA55H0W83JO5ACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
BOS TAURUS SPLEEN190Q9MB3U3ACTIB
ANTIMONY9IT35J3UV3ACTIB
SILVER3M4G523W1GACTIB
HELLEBORUS FOETIDUS ROOT332Y7EES96ACTIB
EQUISETUM ARVENSE TOP1DP6Y6B65ZACTIB
PHOSPHORUS27YLU75U4WACTIB
LEAD2P299V784PACTIB

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
297b26d3-6ab1-df7f-e063-6294a90afbae8f5f2a82-0928-8238-e053-2a95a90a26f02024-12-17WarningsExact identifier
spl id: 297b26d3-6ab1-df7f-e063-6294a90afbae
spl set id: 8f5f2a82-0928-8238-e053-2a95a90a26f0

Reported adverse events (FAERS/openFDA)#

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