Hepataplex

Product NDC
43857-0627
11-digit product format
438570627
Labeler code
43857
Product ID
43857-0627_5ae7720b-a36e-48ea-9ce7-4e3e5a545c64
Type
HUMAN OTC DRUG
Nonproprietary name
Boldo, Carduus Marianus, Chelidonium Majus, Lappa Major, Petroselinum Sativum, Taraxacum Officinale, Glutathione, Hepar Suis, Lycopodium Clavatum, Nux Vomica, Phosphorus
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-09-07
Substance
ARCTIUM LAPPA ROOT; CHELIDONIUM MAJUS WHOLE; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PETROSELINUM CRISPUM WHOLE; PEUMUS BOLDUS LEAF; PHOSPHORUS; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE
Active strength
3; 3; 6; 12; 3; 3; 3; 12; 6; 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
Listing certified through
2027-12-31
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 · 8 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 packagepackage43857-0627-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43857-0627-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43857-0627-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-0627-11332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Hepataplex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEUMUS BOLDUS LEAF3 [hp_X]/mL
MILK THISTLE3 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE6 [hp_X]/mL
ARCTIUM LAPPA ROOT12 [hp_X]/mL
PETROSELINUM CRISPUM WHOLE3 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
GLUTATHIONE3 [hp_X]/mL
PORK LIVER12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q4EWM09M3OInternal UNII lookup
U946SH95EEInternal UNII lookup
7E889U5RNNInternal UNII lookup
597E9BI3Z3Internal UNII lookup
1WZA4Y92EXInternal UNII lookup
39981FM375Internal UNII lookup
GAN16C9B8OInternal UNII lookup
6EC706HI7FInternal UNII lookup
C88X29Y479Internal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
455040e3-becd-4b31-a524-fc1dc5453740Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0627-12024-08-29C16284748780-11030e365-143a-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0627-12024-01-30C16284748780-11030e365-143a-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0627-1Hepataplex30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0627HEPATAPLEX (BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, LAPPA MAJOR, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240830_455040e3-becd-4b31-a524-fc1dc5453740.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
HepataplexBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, LAPPA MAJOR, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSBioActive Nutritional, Inc.455040e3-becd-4b31-a524-fc1dc54537402026-03-10WarningsExact identifier
ndc (product): 43857-0627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0627-14385706270130 mL in 1 BOTTLE, DROPPER (43857-0627-1) 30 ml2022-09-070000-00-00NoNoCurrent