Pancreaplex

Product NDC
43857-0590
11-digit product format
438570590
Labeler code
43857
Product ID
43857-0590_454fd9a2-ace2-4e8c-a059-7a7d0540acbe
Type
HUMAN OTC DRUG
Nonproprietary name
Chelidonium Majus, Glycyrrhiza Glabra, Nux Moschata, Rheum (Palmatum), Syzygium Jambolanum, Taraxacum Officinale, Zingiber Officinale, Hydrastis Canadensis, Glandula Suprarenalis Suis, Hepar Suis, Hypophysis Suis, Pancreas Suis, Thyroidinum (Suis), Phaseolus, Phosphoricum Acidum, Phosphorus
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-06-05
Substance
CHELIDONIUM MAJUS WHOLE; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; KIDNEY BEAN; NUTMEG; PHOSPHORIC ACID; PHOSPHORUS; PORK LIVER; RHEUM PALMATUM ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; THYROID
Active strength
3; 3; 3; 5; 12; 3; 12; 12; 6; 3; 6; 6; 6; 3; 3; 8 [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable 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
Pancreaplex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
GLYCYRRHIZA GLABRA3 [hp_X]/mL
NUTMEG3 [hp_X]/mL
RHEUM PALMATUM ROOT5 [hp_X]/mL
SYZYGIUM CUMINI SEED12 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
GINGER12 [hp_X]/mL
GOLDENSEAL12 [hp_X]/mL
SUS SCROFA ADRENAL GLAND6 [hp_X]/mL
PORK LIVER3 [hp_X]/mL
SUS SCROFA PITUITARY GLAND6 [hp_X]/mL
SUS SCROFA PANCREAS6 [hp_X]/mL
THYROID6 [hp_X]/mL
KIDNEY BEAN3 [hp_X]/mL
PHOSPHORIC ACID3 [hp_X]/mL
PHOSPHORUS8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7E889U5RNNInternal UNII lookup
2788Z9758HInternal UNII lookup
AEE24M3MQ9Internal UNII lookup
G025DAL7CEInternal UNII lookup
820LSF646IInternal UNII lookup
39981FM375Internal UNII lookup
C5529G5JPQInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
398IYQ16YVInternal UNII lookup
6EC706HI7FInternal UNII lookup
L0PFEMQ1DTInternal UNII lookup
9Y3J3362RYInternal UNII lookup
6RV024OAUQInternal UNII lookup
M98C8416QOInternal UNII lookup
E4GA8884NNInternal 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
4f7fbb76-79c0-4c1e-aa30-a39492db63d8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0590-1Pancreaplex30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0590PANCREAPLEX (CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, NUX MOSCHATA, RHEUM (PALMATUM), SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, ZINGIBER OFFICINALE, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, PANCREAS SUIS, THYROIDINUM (SUIS), PHASEOLUS, PHOSPHORICUM ACIDUM, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, 1 package rows20230607_4f7fbb76-79c0-4c1e-aa30-a39492db63d8.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
PancreaplexCHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, NUX MOSCHATA, RHEUM (PALMATUM), SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, ZINGIBER OFFICINALE, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, PANCREAS SUIS, THYROIDINUM (SUIS), PHASEOLUS, PHOSPHORICUM ACIDUM, PHOSPHORUSBioActive Nutritional, Inc.4f7fbb76-79c0-4c1e-aa30-a39492db63d82026-04-03WarningsExact identifier
ndc (product): 43857-0590

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0590-14385705900130 mL in 1 BOTTLE, DROPPER (43857-0590-1) 30 ml2023-06-05NoNoCurrent