Home NDC 48951-5135 Helleborus comp. A
Product NDC 48951-5135
11-digit product format 489515135
Labeler code 48951
Product ID 48951-5135_4420fb70-8e19-709c-e063-6394a90a1e7a
Type HUMAN OTC DRUG
Nonproprietary name Helleborus comp. A
Dosage form LIQUID
Route ORAL
Labeler Uriel Pharmacy Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-03-11
Substance TIN; PHOSPHORUS; ARSENIC TRIOXIDE; LEAD MONOSILICATE; SILVER; FORMICA RUFA; ANTIMONY; HELLEBORUS NIGER ROOT; POTASSIUM PHOSPHATE, MONOBASIC; JUGLANS REGIA LEAF
Active strength 12; 12; 17; 20; 8; 6; 6; 3; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 comp. A
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIN 12 [hp_X]/mL PHOSPHORUS 12 [hp_X]/mL ARSENIC TRIOXIDE 17 [hp_X]/mL LEAD MONOSILICATE 20 [hp_X]/mL SILVER 8 [hp_X]/mL FORMICA RUFA 6 [hp_X]/mL ANTIMONY 6 [hp_X]/mL HELLEBORUS NIGER ROOT 3 [hp_X]/mL POTASSIUM PHOSPHATE, MONOBASIC 6 [hp_X]/mL JUGLANS REGIA LEAF 7 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 48951-5135-1 Helleborus comp. A 1 mL in 1 AMPULE LIQUID 1 3 48951-5135-1 Helleborus comp. A 10 in 1 BOX LIQUID 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48951-5135 HELLEBORUS COMP. A LIQUID [URIEL PHARMACY INC.] 2 Current NDC, 2 package rows 20241219_150e57ad-3ed7-5cc9-e063-6394a90a25fe.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 48951-5135-1 48951513501 10 AMPULE in 1 BOX (48951-5135-1) / 1 mL in 1 AMPULE 10 ampule 2021-03-11 No No Current