FDA.reportPublic FDA data

Helleborus comp. D

Manufacturer
Uriel Pharmacy Inc.
Effective date
2026-10-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-11-03 06:04:45

Label at a glance#

ProductHelleborus comp. D
Active ingredientORYCTOLAGUS CUNICULUS LIVER, HYOSCYAMUS NIGER LEAF, SLOE, GOLD, HELLEBORUS NIGER ROOT, IRON, MAGNESIUM HYDROXIDE
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: Hyoscyamus (Henbane) 4X, Helleborus (Christmas rose) 6X, Hepar oryctolagus (Lliver) 6X, Magnesium hydroxydatum (Magnesium hydroxide) 6X, Prunus (Blackthorn) 6X, Aurum met. (Metallic gold) 10X, Meteoric iron 12X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

Prepared using rhythmical processes

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus comp D AmpuleHelleborus comp D AmpuleHel com D Amp

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
48951-5117-12026-01-29C16284748780-149896155-ae1a-586f-e063-e6dba90add90Helleborus comp. D

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-515148951-5151-1

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
ORYCTOLAGUS CUNICULUS LIVER7A99K6361ZACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
SLOE3MLB4858X7ACTIB
GOLD79Y1949PYOACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
IRONE1UOL152H7ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-08full-release2026-06-01 02:28:12

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 set id: 8f636d53-b433-57c7-e053-2995a90a0ad3

Reported adverse events (FAERS/openFDA)#

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