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
GINGER3 [hp_X]/mL
GLYCYRRHIZA GLABRA3 [hp_X]/mL
GOLDENSEAL5 [hp_X]/mL
KIDNEY BEAN12 [hp_X]/mL
NUTMEG3 [hp_X]/mL
PHOSPHORIC ACID12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PORK LIVER6 [hp_X]/mL
RHEUM PALMATUM ROOT3 [hp_X]/mL
SUS SCROFA ADRENAL GLAND6 [hp_X]/mL
SUS SCROFA PANCREAS6 [hp_X]/mL
SUS SCROFA PITUITARY GLAND6 [hp_X]/mL
SYZYGIUM CUMINI SEED3 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
THYROID8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7E889U5RNN, C5529G5JPQ, 2788Z9758H, ZW3Z11D0JV, M98C8416QO, AEE24M3MQ9, E4GA8884NN, 27YLU75U4W, 6EC706HI7F, G025DAL7CE, 398IYQ16YV, 9Y3J3362RY, L0PFEMQ1DT, 820LSF646I, 39981FM375, 6RV024OAUQ

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

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 ml2023-06-05NoNoHistorical