Helleborus niger 6X

Product NDC
48951-5124
11-digit product format
489515124
Labeler code
48951
Product ID
48951-5124_c6b6ee84-62ec-0c1b-e053-2995a90abffb
Type
HUMAN OTC DRUG
Nonproprietary name
Helleborus niger 6X
Dosage form
LIQUID
Route
ORAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
HELLEBORUS NIGER ROOT
Active strength
6 [hp_X]/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Helleborus niger 6X
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELLEBORUS NIGER ROOT6 [hp_X]/mL

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
c6b61b73-a03f-c730-e053-2a95a90a2e90Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5124-1Helleborus niger 6X1 mL in 1 AMPULELIQUID15
48951-5124-1Helleborus niger 6X8 in 1 BOXLIQUID85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5124HELLEBORUS NIGER 6X LIQUID [URIEL PHARMACY INC.]5Legacy NDC, 2 package rows20241212_c6b61b73-a03f-c730-e053-2a95a90a2e90.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 niger 6XHELLEBORUS NIGER 6XUriel Pharmacy Inc.c6b61b73-a03f-c730-e053-2a95a90a2e902026-09-03WarningsExact identifier
ndc (product): 48951-5124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-5124-1489515124018 AMPULE in 1 BOX (48951-5124-1) > 1 mL in 1 AMPULE8 ampule2009-09-010000-00-00NoNoCurrent