FDA.reportPublic FDA data

Helleborus niger

Manufacturer
Washington Homeopathic Products
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:31:37

Label at a glance#

ProductHelleborus niger
Active ingredientHELLEBORUS NIGER ROOT
Label structure8 sections

Indications and uses

Indicated for Pale skin.

Dosage and administration

(Adults or Children): Dissolve 3 to 5 pellets under tongue 3 times a day or as directed by a licensed practitioner. Take at greater intervals as condition subsides.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Helleborus niger 200C

USES

OTC - PURPOSE SECTION

Indicated for Pale skin.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

As with all medications, keep out of reach of children.

INDICATIONS

INDICATIONS & USAGE SECTION

Helleborus niger indicated for Pale Skin.

STOP USE AND ASK DOCTOR

WARNINGS SECTION

If symptoms persist or recur, discontinue use. If pregnant or nursing, consult a licensed practitioner before using this product.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

(Adults or Children): Dissolve 3 to 5 pellets under tongue 3 times a day or as directed by a licensed practitioner. Take at greater intervals as condition subsides.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose/Lactose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus kit refill 200cHelleborus kit refill 200c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71919-818-01Helleborus niger350 in 1 VIAL, GLASSPELLET3503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71919-818HELLEBORUS NIGER (HELLEBORUS NIGER ROOT) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3Current NDC, 1 package rows20250130_0996cbde-0212-ee6b-e063-6394a90a4820.zip

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
71919-81871919-818-01

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
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB

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
Helleborus nigerHELLEBORUS NIGER ROOTWashington Homeopathic Products0996cbde-0212-ee6b-e063-6394a90a48202025-01-28WarningsExact identifier
ndc (package): 71919-818-01
ndc (product): 71919-818
ndc11 (package): 71919081801
spl id: 2cc87829-1807-784b-e063-6394a90ae295
spl set id: 0996cbde-0212-ee6b-e063-6394a90a4820

Reported adverse events (FAERS/openFDA)#

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