Hepapar

Product NDC
44911-0516
11-digit product format
449110516
Labeler code
44911
Product ID
44911-0516_8d8552df-3dfa-45ee-a686-94593c464dcf
Type
HUMAN OTC DRUG
Nonproprietary name
Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Boldo, Hepar Suis, Lycopodium Clavatum, Mercurius Solubilis, Natrum Sulphuricum, Nux Vomica, Phosphorus, Chenopodium Anthelminticum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-25
Marketing end
2027-08-02
Substance
CHELIDONIUM MAJUS WHOLE; DYSPHANIA AMBROSIOIDES WHOLE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; MILK THISTLE; PEUMUS BOLDUS LEAF; PHOSPHORUS; PORK LIVER; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE
Active strength
3; 16; 12; 12; 3; 6; 12; 6; 12; 12; 3 [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
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
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 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage44911-0516-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage44911-0516-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage44911-0516-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0516-11332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage44911-0516-18dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

Finished product
Yes
Brand name base
Hepapar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILK THISTLE3 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE16 [hp_X]/mL
TARAXACUM OFFICINALE12 [hp_X]/mL
PEUMUS BOLDUS LEAF12 [hp_X]/mL
PORK LIVER3 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
SODIUM SULFATE6 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
DYSPHANIA AMBROSIOIDES WHOLE3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U946SH95EEInternal UNII lookup
7E889U5RNNInternal UNII lookup
39981FM375Internal UNII lookup
Q4EWM09M3OInternal UNII lookup
6EC706HI7FInternal UNII lookup
C88X29Y479Internal UNII lookup
324Y4038G2Internal UNII lookup
0YPR65R21JInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
4H5RSU087IInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c670a50-16db-42a4-bc29-02818e27ea85Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-08-26Drug Facts:
2024-01-30Drug Facts:
2022-03-09Drug Facts:
2021-01-29Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0516-1Hepapar30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0516HEPAPAR (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, BOLDO, HEPAR SUIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, CHENOPODIUM ANTHELMINTICUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240828_9c670a50-16db-42a4-bc29-02818e27ea85.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HepaparCARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, BOLDO, HEPAR SUIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, CHENOPODIUM ANTHELMINTICUMEnergique, Inc.9c670a50-16db-42a4-bc29-02818e27ea852024-08-26WarningsExact identifier
ndc (product): 44911-0516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0516-14491105160130 mL in 1 BOTTLE, DROPPER (44911-0516-1) 30 ml2019-10-252027-08-02NoNoCurrent