FDA.reportPublic FDA data

Hepatone

Product NDC
44911-0259
11-digit product format
449110259
Labeler code
44911
Product ID
44911-0259_02f2758b-378d-4946-89cd-9cfed550a62f
Type
HUMAN OTC DRUG
Nonproprietary name
Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-09-04
Substance
CHELIDONIUM MAJUS WHOLE; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE
Active strength
3; 12; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hepatone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
MILK THISTLE3 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
SODIUM SULFATE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7E889U5RNN, C88X29Y479, U946SH95EE, 27YLU75U4W, 0YPR65R21J, 269XH13919, 39981FM375

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:
44911-0259-12022-01-28C16284748780-19d75b9d0-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:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0259-1Hepatone30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNNHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
MILK THISTLEACTIVE INGREDIENTU946SH95EEHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21JHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
TARAXACUM OFFICINALEACTIVE INGREDIENT39981FM375HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNNHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
MILK THISTLEACTIVE MOIETYU946SH95EEHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
PHOSPHORUSACTIVE MOIETY27YLU75U4WHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R750HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
TARAXACUM OFFICINALEACTIVE MOIETY39981FM375HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0259HEPATONE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20241027_51064a35-bf55-4905-a305-7b80a29417e9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0259-14491102590130 mL in 1 BOTTLE, DROPPER (44911-0259-1) 30 ml2015-09-040000-00-00NoNoCurrent