FDA.reportPublic FDA data

Spleenex

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:20:13

Label at a glance#

ProductSpleenex V
Active ingredientAMERICAN GINSENG, MAGNESIUM GLUCONATE, POTASSIUM GLUCONATE, GINKGO, SUS SCROFA PANCREAS, SUS SCROFA SPLEEN, SUS SCROFA STOMACH, GERMANIUM SESQUIOXIDE, COPPER, ZINC, OXOGLURIC ACID, ANHYDROUS CITRIC ACID, FUMARIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, MALIC ACID, OXALOACETIC ACID, PYRUVIC ACID, SUCCINIC ACID, 1,4-NAPHTHOQUINONE, ACONITIC ACID, (Z)-
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aralia Quinquefolia 3X, 6X, 12X, 30X, Magnesium Gluconicum Dihydricum 3X, 6X, 12X, 30X, Potassium Gluconate 3X, 6X, 12X, 30X, Ginkgo Biloba 6X, Pancreas Suis 6X, 12X, 30X, Spleen (Suis) 6X, 12X, 30X, Stomach 6X, 12X, 30X, Germanium Sesquioxide 8X, Cuprum Metallicum 8X, 12X, Zincum Metallicum 8X, 12X, alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Fumaricum Acidum 8X, 12X, 30X, Magnesia Phosphorica 8X, 12X, 30X, Malic Acid 8X, 12X, 30X, Oxaloacetic Acid 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X, Succinicum Acidum 8X, 12X, 30X, Naphthoquinone 9X, 12X, 30X, Aconitum Acidum, Cis- 12X, 30X.

INDICATIONS:

OTC - PURPOSE SECTION

Spleen, Pancreas, Stomach support.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional.

Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Spleen, Pancreas, Stomach support.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SPLEENEX V

1 fl. oz. (30 ml)

SPLEENEX VSPLEENEX V

SPLEENEX VSPLEENEX V

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0233-12021-12-29C16284748780-19d75b9d0-799f-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0233-12020-01-31C16284748780-19d75b9d0-799f-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
1,4-NAPHTHOQUINONEACTIVE INGREDIENTRBF5ZU7R7K1
ACONITIC ACID, (Z)-ACTIVE INGREDIENTOF5471ZHRR1
AMERICAN GINSENGACTIVE INGREDIENT8W75VCV53Q1
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSL1
COPPERACTIVE INGREDIENT789U1901C51
FUMARIC ACIDACTIVE INGREDIENT88XHZ131311
GERMANIUM SESQUIOXIDEACTIVE INGREDIENT96WE91N25T1
GINKGOACTIVE INGREDIENT19FUJ2C58T1
MAGNESIUM GLUCONATEACTIVE INGREDIENTT42NAD2KHC1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q1
MALIC ACIDACTIVE INGREDIENT817L1N4CKP1
OXALOACETIC ACIDACTIVE INGREDIENT2F399MM81J1
OXOGLURIC ACIDACTIVE INGREDIENT8ID597Z82X1
POTASSIUM GLUCONATEACTIVE INGREDIENT12H3K5QKN91
PYRUVIC ACIDACTIVE INGREDIENT8558G7RUTR1
SUCCINIC ACIDACTIVE INGREDIENTAB6MNQ6J6L1
SUS SCROFA PANCREASACTIVE INGREDIENT9Y3J3362RY1
SUS SCROFA SPLEENACTIVE INGREDIENT92AMN5J79Y1
SUS SCROFA STOMACHACTIVE INGREDIENTT0920P9Z9A1
ZINCACTIVE INGREDIENTJ41CSQ7QDS1
.ALPHA.-KETOGLUTARIC ACIDACTIVE MOIETY8ID597Z82X1
1,4-NAPHTHOQUINONEACTIVE MOIETYRBF5ZU7R7K1
ACONITIC ACID, (Z)-ACTIVE MOIETYOF5471ZHRR1
AMERICAN GINSENGACTIVE MOIETY8W75VCV53Q1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL1
COPPERACTIVE MOIETY789U1901C51
FUMARIC ACIDACTIVE MOIETY88XHZ131311
GERMANIUM SESQUIOXIDEACTIVE MOIETY96WE91N25T1
GINKGOACTIVE MOIETY19FUJ2C58T1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
MALIC ACIDACTIVE MOIETY817L1N4CKP1
OXALOACETIC ACIDACTIVE MOIETY2F399MM81J1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
PYRUVIC ACIDACTIVE MOIETY8558G7RUTR1
SUCCINIC ACIDACTIVE MOIETYAB6MNQ6J6L1
SUS SCROFA PANCREASACTIVE MOIETY9Y3J3362RY1
SUS SCROFA SPLEENACTIVE MOIETY92AMN5J79Y1
SUS SCROFA STOMACHACTIVE MOIETYT0920P9Z9A1
ZINCACTIVE MOIETYJ41CSQ7QDS1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-023344911-0233-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMERICAN GINSENG8W75VCV53QACTIB
MAGNESIUM GLUCONATET42NAD2KHCACTIB
POTASSIUM GLUCONATE12H3K5QKN9ACTIB
GINKGO19FUJ2C58TACTIB
SUS SCROFA PANCREAS9Y3J3362RYACTIB
SUS SCROFA SPLEEN92AMN5J79YACTIB
SUS SCROFA STOMACHT0920P9Z9AACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
COPPER789U1901C5ACTIB
ZINCJ41CSQ7QDSACTIB
OXOGLURIC ACID8ID597Z82XACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
FUMARIC ACID88XHZ13131ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
MALIC ACID817L1N4CKPACTIB
OXALOACETIC ACID2F399MM81JACTIB
PYRUVIC ACID8558G7RUTRACTIB
SUCCINIC ACIDAB6MNQ6J6LACTIB
1,4-NAPHTHOQUINONERBF5ZU7R7KACTIB
ACONITIC ACID, (Z)-OF5471ZHRRACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d7fa7857-8802-42e1-9453-e78b3fe71aac76b2dffa-c7f1-41fb-9e9a-38221f0d566f2021-12-29WarningsExact identifier
spl id: d7fa7857-8802-42e1-9453-e78b3fe71aac
spl set id: 76b2dffa-c7f1-41fb-9e9a-38221f0d566f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.