FDA.reportPublic FDA data

Helleborus niger

Product NDC
0220-2450
11-digit product format
002202450
Labeler code
0220
Product ID
0220-2450_003a848f-c8d0-0cb1-e063-6294a90a6602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HELLEBORUS NIGER ROOT
Dosage form
PELLET
Route
ORAL
Labeler
Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1983-03-03
Substance
HELLEBORUS NIGER ROOT
Active strength
200 [kp_C]/200[kp_C]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Helleborus niger
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELLEBORUS NIGER ROOT200 [kp_C]/200[kp_C]

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
608DGJ6815Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85b5c79a-5177-e5c0-e053-2991aa0a6ca3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-2450-412023-07-11C16284748780-1f386c649-df86-0266-e053-dadaa90a7c1aHelleborus niger 200CK
0220-2450-412023-01-30C16284748780-1f386c649-df86-0266-e053-dadaa90a7c1aHelleborus niger 200CK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-2450-41Helleborus niger200 [kp_C] in 1 TUBEPELLET2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-2450HELLEBORUS NIGER (HELLEBORUS NIGER ROOT ) PELLET [BOIRON]2Current NDC, Legacy NDC, 1 package rows20230712_85b5c79a-5177-e5c0-e053-2991aa0a6ca3.zip

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 ROOTBoiron85b5c79a-5177-e5c0-e053-2991aa0a6ca32023-07-11Exact identifier
ndc (product): 0220-2450

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0220-2450-4100220245041200 [kp_C] in 1 TUBE (0220-2450-41) 1983-03-030000-00-00NoNoCurrent