FDA.reportPublic FDA data

Helleborus Niger

Manufacturer
Hahnemann Laboratories, INC.
Effective date
2022-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:18:14

Label at a glance#

ProductHelleborus Niger
Active ingredientHELLEBORUS NIGER ROOT
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus Niger 6C 5gHelleborus Niger 6C 5gHelleborus Niger 6C 30gHelleborus Niger 6C 30gHelleborus Niger 6C 100gHelleborus Niger 6C 100gHelleborus Niger 12C 5gHelleborus Niger 12C 5gHelleborus Niger 12C 30gHelleborus Niger 12C 30gHelleborus Niger 12C 100gHelleborus Niger 12C 100gHelleborus Niger 30C 1gHelleborus Niger 30C 1gHelleborus Niger 30C 5gHelleborus Niger 30C 5gHelleborus Niger 30C 30gHelleborus Niger 30C 30gHelleborus Niger 30C 100gHelleborus Niger 30C 100gHelleborus Niger 100C 1gHelleborus Niger 100C 1gHelleborus Niger 100C 5gHelleborus Niger 100C 5gHelleborus Niger 100C 30gHelleborus Niger 100C 30gHelleborus Niger 100C 100gHelleborus Niger 100C 100gHelleborus Niger 200C 1gHelleborus Niger 200C 1gHelleborus Niger 200C 5gHelleborus Niger 200C 5gHelleborus Niger 200C 30gHelleborus Niger 200C 30gHelleborus Niger 200C 100gHelleborus Niger 200C 100gHelleborus Niger 500C 1gHelleborus Niger 500C 1gHelleborus Niger 500C 5gHelleborus Niger 500C 5gHelleborus Niger 500C 30gHelleborus Niger 500C 30gHelleborus Niger 500C 100gHelleborus Niger 500C 100gHelleborus Niger 1M 1gHelleborus Niger 1M 1gHelleborus Niger 1M 5gHelleborus Niger 1M 5gHelleborus Niger 1M 30gHelleborus Niger 1M 30gHelleborus Niger 1M 100gHelleborus Niger 1M 100gHelleborus Niger 10M 1gHelleborus Niger 10M 1gHelleborus Niger 10M 5gHelleborus Niger 10M 5gHelleborus Niger 10M 30gHelleborus Niger 10M 30gHelleborus Niger 10M 100gHelleborus Niger 10M 100gHelleborus Niger LM1 30gHelleborus Niger LM1 30g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37662-1656-1Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1656-2Helleborus Niger1200 in 1 BOTTLE, GLASSPELLET12001
37662-1656-3Helleborus Niger4000 in 1 BOTTLE, GLASSPELLET40001
37662-1657-1Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1657-2Helleborus Niger1200 in 1 BOTTLE, GLASSPELLET12001
37662-1657-3Helleborus Niger4000 in 1 BOTTLE, GLASSPELLET40001
37662-1658-1Helleborus Niger80 in 1 VIAL, GLASSPELLET801
37662-1658-2Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1658-3Helleborus Niger1200 in 1 BOTTLE, GLASSPELLET12001
37662-1658-4Helleborus Niger4000 in 1 BOTTLE, GLASSPELLET40001
37662-1659-1Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1659-2Helleborus Niger500 in 1 VIAL, GLASSPELLET5001
37662-1659-3Helleborus Niger3000 in 1 BOTTLE, GLASSPELLET30001
37662-1659-4Helleborus Niger10000 in 1 BOTTLE, GLASSPELLET100001
37662-1660-1Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1660-2Helleborus Niger500 in 1 VIAL, GLASSPELLET5001
37662-1660-3Helleborus Niger3000 in 1 BOTTLE, GLASSPELLET30001
37662-1660-4Helleborus Niger10000 in 1 BOTTLE, GLASSPELLET100001
37662-1661-1Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1661-2Helleborus Niger500 in 1 VIAL, GLASSPELLET5001
37662-1661-3Helleborus Niger3000 in 1 BOTTLE, GLASSPELLET30001
37662-1661-4Helleborus Niger10000 in 1 BOTTLE, GLASSPELLET100001
37662-1662-1Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1662-2Helleborus Niger500 in 1 VIAL, GLASSPELLET5001
37662-1662-3Helleborus Niger3000 in 1 BOTTLE, GLASSPELLET30001
37662-1662-4Helleborus Niger10000 in 1 BOTTLE, GLASSPELLET100001
37662-1663-1Helleborus Niger200 in 1 VIAL, GLASSPELLET2001
37662-1663-2Helleborus Niger500 in 1 VIAL, GLASSPELLET5001
37662-1663-3Helleborus Niger3000 in 1 BOTTLE, GLASSPELLET30001
37662-1663-4Helleborus Niger10000 in 1 BOTTLE, GLASSPELLET100001
37662-1664-1Helleborus Niger10000 in 1 BOTTLE, GLASSPELLET100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37662-1656HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1657HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1658HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1659HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1660HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1661HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1662HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1663HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip
37662-1664HELLEBORUS NIGER PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20221005_ea2b8bdf-9420-626f-e053-2a95a90a5181.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37662-165637662-1656-1, 37662-1656-2, 37662-1656-3
37662-165737662-1657-1, 37662-1657-2, 37662-1657-3
37662-165837662-1658-1, 37662-1658-2, 37662-1658-3, 37662-1658-4
37662-165937662-1659-1, 37662-1659-2, 37662-1659-3, 37662-1659-4
37662-166037662-1660-1, 37662-1660-2, 37662-1660-3, 37662-1660-4
37662-166137662-1661-1, 37662-1661-2, 37662-1661-3, 37662-1661-4
37662-166237662-1662-1, 37662-1662-2, 37662-1662-3, 37662-1662-4
37662-166337662-1663-1, 37662-1663-2, 37662-1663-3, 37662-1663-4
37662-166437662-1664-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
SUCROSEC151H8M554IACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
SUCROSEC151H8M554IACT
SUCROSEC151H8M554IACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
SUCROSEC151H8M554IACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
SUCROSEC151H8M554IACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
SUCROSEC151H8M554IACT
SUCROSEC151H8M554IACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
SUCROSEC151H8M554IACT
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 NIGERHahnemann Laboratories, INC.ea2b8bdf-9420-626f-e053-2a95a90a51812022-10-03Exact identifier
ndc (package): 37662-1658-3
ndc (package): 37662-1662-1
ndc (package): 37662-1661-3
ndc (package): 37662-1663-4
ndc (package): 37662-1658-2
ndc (package): 37662-1659-2
ndc (package): 37662-1663-3
ndc (package): 37662-1664-1
ndc (package): 37662-1660-3
ndc (package): 37662-1661-1
ndc (package): 37662-1661-2
ndc (package): 37662-1659-3
ndc (package): 37662-1663-1
ndc (package): 37662-1663-2
ndc (package): 37662-1656-2
ndc (package): 37662-1657-3
ndc (package): 37662-1657-1
ndc (package): 37662-1662-4
ndc (package): 37662-1660-4
ndc (package): 37662-1658-4
ndc (package): 37662-1656-3
ndc (package): 37662-1659-1
ndc (package): 37662-1658-1
ndc (package): 37662-1657-2
ndc (package): 37662-1660-1
ndc (package): 37662-1662-3
ndc (package): 37662-1659-4
ndc (package): 37662-1662-2
ndc (package): 37662-1661-4
ndc (package): 37662-1660-2
ndc (package): 37662-1656-1
ndc (product): 37662-1656
ndc (product): 37662-1657
ndc (product): 37662-1661
ndc (product): 37662-1662
ndc (product): 37662-1660
ndc (product): 37662-1664
ndc (product): 37662-1659
ndc (product): 37662-1658
ndc (product): 37662-1663
ndc11 (package): 37662166401
ndc11 (package): 37662166004
ndc11 (package): 37662165702
ndc11 (package): 37662166003
ndc11 (package): 37662166302
ndc11 (package): 37662166301
ndc11 (package): 37662165904
ndc11 (package): 37662165801
ndc11 (package): 37662166102
ndc11 (package): 37662165603
ndc11 (package): 37662165602
ndc11 (package): 37662166101
ndc11 (package): 37662165601
ndc11 (package): 37662165901
ndc11 (package): 37662166001
ndc11 (package): 37662165802
ndc11 (package): 37662165803
ndc11 (package): 37662166002
ndc11 (package): 37662166104
ndc11 (package): 37662166303
ndc11 (package): 37662165903
ndc11 (package): 37662165902
ndc11 (package): 37662165703
ndc11 (package): 37662166201
ndc11 (package): 37662166204
ndc11 (package): 37662166203
ndc11 (package): 37662165804
ndc11 (package): 37662165701
ndc11 (package): 37662166103
ndc11 (package): 37662166202
ndc11 (package): 37662166304
spl id: ea2b8bdf-9421-626f-e053-2a95a90a5181
spl set id: ea2b8bdf-9420-626f-e053-2a95a90a5181

Reported adverse events (FAERS/openFDA)#

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