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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTIUM LAPPA ROOT3 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
GLUTATHIONE6 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
MILK THISTLE3 [hp_X]/mL
PETROSELINUM CRISPUM WHOLE3 [hp_X]/mL
PEUMUS BOLDUS LEAF3 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PORK LIVER6 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii597E9BI3Z3, 7E889U5RNN, GAN16C9B8O, C88X29Y479, U946SH95EE, 1WZA4Y92EX, Q4EWM09M3O, 27YLU75U4W, 6EC706HI7F, 269XH13919, 39981FM375

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

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