Home NDC 44911-0449 Systemistat
Product NDC 44911-0449
11-digit product format 449110449
Labeler code 44911
Product ID 44911-0449_babfa6e6-4ea6-4937-af61-795cc3cb257e
Type HUMAN OTC DRUG
Nonproprietary name Berberis Vulgaris, Chelidonium Majus, Lappa Major, Hydrastis Canadensis, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sulphur, Calcarea Carbonica, Mercurius Solubilis, Thuja Occidentalis
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2018-03-06
Substance BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS WHOLE; ARCTIUM LAPPA ROOT; GOLDENSEAL; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MERCURIUS SOLUBILIS; THUJA OCCIDENTALIS LEAFY TWIG
Active strength 3; 3; 3; 5; 12; 12; 12; 30; 30; 30 [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 Systemistat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL CHELIDONIUM MAJUS WHOLE 3 [hp_X]/mL ARCTIUM LAPPA ROOT 3 [hp_X]/mL GOLDENSEAL 5 [hp_X]/mL CALCIUM SULFIDE 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL SULFUR 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_X]/mL MERCURIUS SOLUBILIS 30 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 30 [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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0449-1 Systemistat 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0449 SYSTEMISTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20230422_0d8aa575-3fae-4828-8827-d2561672a91e.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Systemistat BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA OCCIDENTALIS Energique, Inc. 0d8aa575-3fae-4828-8827-d2561672a91e 2023-04-21 Warnings Exact identifier ndc (product): 44911-0449
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0449-1 44911044901 30 mL in 1 BOTTLE, DROPPER (44911-0449-1) 30 ml 2018-03-06 0000-00-00 No No Current