FDA.reportPublic FDA data

Pancreaplex

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-06-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:30:15

Label at a glance#

ProductPancreaplex
Active ingredientCHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, GOLDENSEAL, NUTMEG, RHEUM OFFICINALE ROOT, SYZYGIUM CUMINI SEED, TARAXACUM OFFICINALE, GINGER, SUS SCROFA ADRENAL GLAND, PORK LIVER, SUS SCROFA PANCREAS, SUS SCROFA PITUITARY GLAND, POSTERIOR, SUS SCROFA THYROID, KIDNEY BEAN, PHOSPHORIC ACID, PHOSPHORUS
Label structure9 sections

Indications and uses

For temporary relief of nervous anxiety, afternoon headache, feeling faint relieved by eating, craving of sweets, nervousness if meals missed.

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Chelidonium Majus 3X, Glycyrrhiza Glabra 3X, Hydrastis Canadensis 3X, Nux Moschata 3X, Rheum Officinale 3X, Syzygium Jambolanum 3X, Taraxacum Officinale 3X, Zingiber Officinale 3X, Glandula Suprarenalis Suis 6X, Hepar Suis 6X, Pancreas Suis 6X, Pituitary (Suis) 6X, Thyroidinum (Suis) 8X, Phaseolus 12X, Phosphoricum Acidum 12X, Phosphorus 12X

INDICATIONS

OTC - PURPOSE SECTION

For temporary relief of nervous anxiety, afternoon headache, feeling faint relieved by eating, craving of sweets, nervousness if meals missed.

WARNINGS

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For temporary relief of nervous anxiety, afternoon headache, feeling faint relieved by eating, craving of sweets, nervousness if meals missed.

QUESTIONS

OTC - QUESTIONS SECTION

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

PANCREAPLEX

1 FL OZ (30 ml)

PancreaplexPancreaplex

PancreaplexPancreaplex

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0104-12023-06-08C16284748780-19d75b9d0-049f-f424-e053-dadaa90a57ceDrug Facts
43857-0104-12020-01-31C16284748780-19d75b9d0-049f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN2
GINGERACTIVE INGREDIENTC5529G5JPQ2
GLYCYRRHIZA GLABRAACTIVE INGREDIENT2788Z9758H2
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV2
KIDNEY BEANACTIVE INGREDIENTM98C8416QO2
NUTMEGACTIVE INGREDIENTAEE24M3MQ92
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN2
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W2
PORK LIVERACTIVE INGREDIENT6EC706HI7F2
RHEUM OFFICINALE ROOTACTIVE INGREDIENTA47JP5ZG9M2
SUS SCROFA ADRENAL GLANDACTIVE INGREDIENT398IYQ16YV2
SUS SCROFA PANCREASACTIVE INGREDIENT9Y3J3362RY2
SUS SCROFA PITUITARY GLANDACTIVE INGREDIENTE8S87O660T2
SUS SCROFA THYROIDACTIVE INGREDIENT6RV024OAUQ2
SYZYGIUM CUMINI SEEDACTIVE INGREDIENT820LSF646I2
TARAXACUM OFFICINALEACTIVE INGREDIENT39981FM3752
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN2
GINGERACTIVE MOIETYC5529G5JPQ2
GLYCYRRHIZA GLABRAACTIVE MOIETY2788Z9758H2
GOLDENSEALACTIVE MOIETYZW3Z11D0JV2
KIDNEY BEANACTIVE MOIETYM98C8416QO2
NUTMEGACTIVE MOIETYAEE24M3MQ92
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN2
PHOSPHORUSACTIVE MOIETY27YLU75U4W2
PORK LIVERACTIVE MOIETY6EC706HI7F2
RHEUM OFFICINALE ROOTACTIVE MOIETYA47JP5ZG9M2
SUS SCROFA ADRENAL GLANDACTIVE MOIETY398IYQ16YV2
SUS SCROFA PANCREASACTIVE MOIETY9Y3J3362RY2
SUS SCROFA PITUITARY GLANDACTIVE MOIETYE8S87O660T2
SUS SCROFA THYROIDACTIVE MOIETY6RV024OAUQ2
SYZYGIUM CUMINI SEEDACTIVE MOIETY820LSF646I2
TARAXACUM OFFICINALEACTIVE MOIETY39981FM3752
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-010443857-0104-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHELIDONIUM MAJUS7E889U5RNNACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
GOLDENSEALZW3Z11D0JVACTIB
NUTMEGAEE24M3MQ9ACTIB
RHEUM OFFICINALE ROOTA47JP5ZG9MACTIB
SYZYGIUM CUMINI SEED820LSF646IACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
GINGERC5529G5JPQACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
PORK LIVER6EC706HI7FACTIB
SUS SCROFA PANCREAS9Y3J3362RYACTIB
SUS SCROFA PITUITARY GLAND, POSTERIORE8S87O660TACTIB
SUS SCROFA THYROID6RV024OAUQACTIB
KIDNEY BEANM98C8416QOACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
c40c585c-f330-4231-ae9b-bad076abfb4430445a15-fab1-4ee2-99d6-ab7e6dc6105c2023-06-08WarningsExact identifier
spl id: c40c585c-f330-4231-ae9b-bad076abfb44
spl set id: 30445a15-fab1-4ee2-99d6-ab7e6dc6105c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.