FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2026-08-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-13 01:00:59

Label at a glance#

ProductHepatone
Active ingredientMILK THISTLE, CHELIDONIUM MAJUS WHOLE, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
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 for more than 7 days, 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

(in each drop): 24.93% of Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X; 0.10% of Carduus Marianus 3X, Chelidonium Majus 3X, Taraxacum Officinale 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve flatulence, constipation, and salty or bitter taste in mouth.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. 

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 for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve flatulence, constipation, and salty or bitter taste in mouth.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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

HEPATONE

1 fl. oz. (30 ml)

HepatoneHepatone

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363113700701GTIN-13: 0363113700701
EAN-13: 0363113700701
GTIN-12: 363113700701
UPC-A: 363113700701
GTIN storage (14 digits): 00363113700701		ENRG0674 Hepatone 7-29-2020.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0259-12024-10-25C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0259-12024-10-25C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0259-12022-01-28C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0259-12022-01-28C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0259-12020-06-26C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0259-12020-06-26C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0259-12020-01-31C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0259-12020-01-31C16284748780-19d75b9d0-fd81-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
MILK THISTLEACTIVE INGREDIENTU946SH95EE1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
TARAXACUM OFFICINALEACTIVE INGREDIENT39981FM3751
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
MILK THISTLEACTIVE MOIETYU946SH95EE1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
TARAXACUM OFFICINALEACTIVE MOIETY39981FM3751
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-025944911-0259-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-10-25full-release2026-06-01 02:28:25

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
HepatoneCARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.51064a35-bf55-4905-a305-7b80a29417e92026-08-11WarningsExact identifier
ndc (package): 44911-0259-1
ndc (product): 44911-0259
ndc11 (package): 44911025901
spl id: 38df099a-a7a0-43ff-b492-79a5cf16ded4
spl set id: 51064a35-bf55-4905-a305-7b80a29417e9

Reported adverse events (FAERS/openFDA)#

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