Helleborus Niger

Product NDC
37662-1656
11-digit product format
376621656
Labeler code
37662
Product ID
37662-1656_ea2b8bdf-9421-626f-e053-2a95a90a5181
Type
HUMAN OTC DRUG
Nonproprietary name
Helleborus Niger
Dosage form
PELLET
Route
ORAL
Labeler
Hahnemann Laboratories, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-10-03
Substance
HELLEBORUS NIGER ROOT
Active strength
6 [hp_C]/1
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 ROOT6 [hp_C]/1

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
ea2b8bdf-9420-626f-e053-2a95a90a5181Available on FDA.report

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

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

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 (product): 37662-1656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37662-1656-137662165601200 PELLET in 1 VIAL, GLASS (37662-1656-1) 200 pellet2022-10-030000-00-00NoNoCurrent
37662-1656-2376621656021200 PELLET in 1 BOTTLE, GLASS (37662-1656-2) 1200 pellet2022-10-030000-00-00NoNoCurrent
37662-1656-3376621656034000 PELLET in 1 BOTTLE, GLASS (37662-1656-3) 4000 pellet2022-10-030000-00-00NoNoCurrent