Home NDC 44911-0539 Spleenex
Product NDC 44911-0539
11-digit product format 449110539
Labeler code 44911
Product ID 44911-0539_f4520ea3-df0f-4508-b48c-e1e5dc898cbf
Type HUMAN OTC DRUG
Nonproprietary name Aralia Quinquefolia, Potassium Gluconate, Ginkgo Biloba, Magnesium Gluconicum Dihydricum, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malicum Acidum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Aconiticum Acidum, Cis-, Natrum Oxalaceticum
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2020-03-19
Substance ACONITIC ACID, (Z)-; AMERICAN GINSENG; ANHYDROUS CITRIC ACID; COPPER; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; MAGNESIUM GLUCONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MALIC ACID; NAPHTHOQUINE; OXOGLURIC ACID; POTASSIUM GLUCONATE; PYRUVIC ACID; SODIUM DIETHYL OXALACETATE; SUCCINIC ACID; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; ZINC
Active strength 12; 3; 8; 8; 8; 8; 6; 6; 8; 8; 9; 8; 3; 8; 12; 8; 6; 6; 6; 8 [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; [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
Pharmacologic classes Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Coagulation Factor Activity [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 44911-0539-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44911-0539-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44911-0539-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44911-0539-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0539-1 1332a3947898…d4bfe170f9cd…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 44911-0539-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 44911-0539-1 bd6a592717d7…303034d00443…
Additional Listing Data#
Finished product Yes
Brand name base Spleenex
Brand name suffix V
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMERICAN GINSENG 3 [hp_X]/mL POTASSIUM GLUCONATE 3 [hp_X]/mL GINKGO 6 [hp_X]/mL MAGNESIUM GLUCONATE 6 [hp_X]/mL SUS SCROFA PANCREAS 6 [hp_X]/mL SUS SCROFA SPLEEN 6 [hp_X]/mL SUS SCROFA STOMACH 6 [hp_X]/mL GERMANIUM SESQUIOXIDE 8 [hp_X]/mL COPPER 8 [hp_X]/mL ZINC 8 [hp_X]/mL OXOGLURIC ACID 8 [hp_X]/mL ANHYDROUS CITRIC ACID 8 [hp_X]/mL FUMARIC ACID 8 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X]/mL MALIC ACID 8 [hp_X]/mL PYRUVIC ACID 8 [hp_X]/mL SUCCINIC ACID 8 [hp_X]/mL NAPHTHOQUINE 9 [hp_X]/mL ACONITIC ACID, (Z)- 12 [hp_X]/mL SODIUM DIETHYL OXALACETATE 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 20 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 44911-0539-1 SpleenexV 30 mL in 1 BOTTLE, DROPPER LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0539 SPLEENEX V (ARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUM) LIQUID [ENERGIQUE, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241101_effbaa07-239b-42f2-afd4-0eeeba7de1fd.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 Spleenex V ARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUM Energique, Inc. effbaa07-239b-42f2-afd4-0eeeba7de1fd 2024-10-30 Warnings Exact identifier ndc (product): 44911-0539
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0539-1 44911053901 30 mL in 1 BOTTLE, DROPPER (44911-0539-1) 30 ml 2020-03-19 0000-00-00 No No Current