FDA.reportPublic FDA data

Helleborus niger 6X

Manufacturer
Uriel Pharmacy Inc.
Effective date
2026-09-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-08 02:01:07

Label at a glance#

ProductHelleborus niger 6X
Active ingredientHELLEBORUS NIGER ROOT
Label structure9 sections

Label contents#

Full prescribing information#

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 intructions to open ampule.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Helleborus niger (Christmas rose) 6X

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:
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 - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus niger 6X Helleborus niger 6X AmpuleHelleborus niger 6X Ampule

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-512448951-5124-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-12-10full-release2026-06-01 02:29:27

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
Helleborus niger 6XHELLEBORUS NIGER 6XUriel Pharmacy Inc.c6b61b73-a03f-c730-e053-2a95a90a2e902026-09-03WarningsExact identifier
ndc (package): 48951-5124-1
ndc (product): 48951-5124
ndc11 (package): 48951512401
spl id: 5a99022f-2d6f-6794-e063-6294a90ac212
spl set id: c6b61b73-a03f-c730-e053-2a95a90a2e90

Reported adverse events (FAERS/openFDA)#

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