Home NDC 53645-2081 Helleborus Niger 29X
Product NDC 53645-2081
11-digit product format 536452081
Labeler code 53645
Product ID 53645-2081_258f1d2e-67ff-d4c4-e063-6294a90afe8b
Type HUMAN OTC DRUG
Nonproprietary name Helleborus Niger
Dosage form LIQUID
Route ORAL
Labeler True Botanica, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2025-05-28
Substance HELLEBORUS NIGER ROOT
Active strength 29 [hp_X]/30mL
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 29X
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HELLEBORUS NIGER ROOT 29 [hp_X]/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 608DGJ6815 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53645-2081-6 Helleborus Niger 29X 30 mL in 1 BOTTLE LIQUID 30 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53645-2081-6 53645208106 30 mL in 1 BOTTLE (53645-2081-6) 30 ml 2025-05-28 No No Current