Helleborus niger

Product NDC
71919-818
11-digit product format
719190818
Labeler code
71919
Product ID
71919-818_2cc87829-1807-784b-e063-6394a90ae295
Type
HUMAN OTC DRUG
Nonproprietary name
HELLEBORUS NIGER ROOT
Dosage form
PELLET
Route
ORAL
Labeler
Washington Homeopathic Products
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-11-07
Substance
HELLEBORUS NIGER ROOT
Active strength
200 [hp_C]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71919-818-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71919-818-010efc9e666f02…f202fb6c5f17…

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 [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
0996cbde-0212-ee6b-e063-6394a90a4820Available on FDA.report

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

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 (product): 71919-818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71919-818-0171919081801350 PELLET in 1 VIAL, GLASS (71919-818-01) 350 pellet2023-11-07NoNoCurrent