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

Additional Listing Data#

Finished product
Yes
Brand name base
Spleenex
Brand name suffix
V
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITIC ACID, (Z)-12 [hp_X]/mL
AMERICAN GINSENG3 [hp_X]/mL
ANHYDROUS CITRIC ACID8 [hp_X]/mL
COPPER8 [hp_X]/mL
FUMARIC ACID8 [hp_X]/mL
GERMANIUM SESQUIOXIDE8 [hp_X]/mL
GINKGO6 [hp_X]/mL
MAGNESIUM GLUCONATE6 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]/mL
MALIC ACID8 [hp_X]/mL
NAPHTHOQUINE9 [hp_X]/mL
OXOGLURIC ACID8 [hp_X]/mL
POTASSIUM GLUCONATE3 [hp_X]/mL
PYRUVIC ACID8 [hp_X]/mL
SODIUM DIETHYL OXALACETATE12 [hp_X]/mL
SUCCINIC ACID8 [hp_X]/mL
SUS SCROFA PANCREAS6 [hp_X]/mL
SUS SCROFA SPLEEN6 [hp_X]/mL
SUS SCROFA STOMACH6 [hp_X]/mL
ZINC8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOF5471ZHRR, 8W75VCV53Q, XF417D3PSL, 789U1901C5, 88XHZ13131, 96WE91N25T, 19FUJ2C58T, T42NAD2KHC, HF539G9L3Q, 817L1N4CKP, TRY8UD4E2H, 8ID597Z82X, 12H3K5QKN9, 8558G7RUTR, 6CA025Y4FG, AB6MNQ6J6L, 9Y3J3362RY, 92AMN5J79Y, T0920P9Z9A, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0539-12024-10-30C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0539-12024-01-30C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0539-12022-04-18C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0539-12022-01-28C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0539-1SpleenexV30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0539SPLEENEX 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.]3Current NDC, Legacy NDC, 1 package rows20241101_effbaa07-239b-42f2-afd4-0eeeba7de1fd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0539-14491105390130 mL in 1 BOTTLE, DROPPER (44911-0539-1) 30 ml2020-03-190000-00-00NoNoCurrent