FDA.reportPublic FDA data

Helleborus comp. D

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:12

Label at a glance#

ProductHelleborus comp. D
Active ingredientBEEF LIVER, HYOSCYAMUS NIGER LEAF, SLOE, GOLD, HELLEBORUS NIGER ROOT, IRON
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: Hyoscyamus (Henbane) 4X, Helleborus (Christmas rose) 6X, Hepar Magnesium (Bovine liver) 6X, Prunus (Blackthorn) 6X, Aurum met. (Metallic gold) 10X, Meteoric iron 12X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus comp. D AmpulesHelleborus comp. D Ampules

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-5117-12026-01-29C16284748780-149896155-ae1a-586f-e063-e6dba90add90Helleborus comp. D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5117-1Helleborus comp. D10 in 1 BOXLIQUID102
48951-5117-1Helleborus comp. D1 mL in 1 AMPULELIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5117HELLEBORUS COMP. D LIQUID [URIEL PHARMACY INC.]2Legacy NDC, 2 package rows20241010_8f636d53-b433-57c7-e053-2995a90a0ad3.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-511748951-5117-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
BEEF LIVERW8N8R55022ACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
SLOE3MLB4858X7ACTIB
GOLD79Y1949PYOACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
IRONE1UOL152H7ACTIB
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
23f87f88-5fbe-5293-e063-6394a90afb4d8f636d53-b433-57c7-e053-2995a90a0ad32024-10-08WarningsExact identifier
spl id: 23f87f88-5fbe-5293-e063-6394a90afb4d
spl set id: 8f636d53-b433-57c7-e053-2995a90a0ad3

Reported adverse events (FAERS/openFDA)#

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