FDA.reportPublic FDA data

Endoplex M

Manufacturer
BioActive Nutritional, Inc | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:14

Label at a glance#

ProductEndoplex M
Active ingredientCHASTE TREE, AMERICAN GINSENG, LYCOPODIUM CLAVATUM SPORE, PETROSELINUM CRISPUM WHOLE, SAW PALMETTO, URTICA DIOICA WHOLE, ZANTHOXYLUM AMERICANUM BARK, PULSATILLA VULGARIS WHOLE, SUS SCROFA ADRENAL GLAND, SUS SCROFA TESTICLE, SUS SCROFA PITUITARY GLAND, SUS SCROFA PROSTATE, CLEMATIS RECTA FLOWERING TOP, JUNIPERUS VIRGINIANA TWIG
Label structure9 sections

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

Agnus Castus 3X, Aralia Quinquefolia 3X, Lycopodium Clavatum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Urtica Dioica 3X, Xanthoxylum Fraxineum 3X, Pulsatilla (Vulgaris) 4X, Glandula Suprarenalis Suis 6X, Hypophysis Suis 6X, Orchitinum (Suis) 6X, Prostate (Suis) 6X, Clematis Erecta 12X, Juniperus Virginiana 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of lowered vitality with depressed feelings, loss of nervous energy and pressure in the testicles.  

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of lowered vitality with depressed feelings, loss of nervous energy and pressure in the testicles.  

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ENDOPLEX M

HOMEOPATHIC

1 FL OZ (30 ml)

Endoplex MEndoplex M

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0508-12024-10-17C16284748780-1ba0f9c33-25f3-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0508-12021-01-29C16284748780-1ba0f9c33-25f3-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0508-1Endoplex M30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0508ENDOPLEX M (AGNUS CASTUS, ARALIA QUINQUEFOLIA, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, SABAL SERRULATA, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, PULSATILLA (VULGARIS), GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, ORCHITINUM (SUIS), PROSTATE (SUIS), CLEMATIS ERECTA, JUNIPERUS VIRGINIANA) LIQUID [BIOACTIVE NUTRITIONAL, INC]2Current NDC, Legacy NDC, 1 package rows20241019_344a27cb-f15e-4a9f-87f4-c2627f02db77.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-050843857-0508-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHASTE TREE433OSF3U8AACTIB
AMERICAN GINSENG8W75VCV53QACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PETROSELINUM CRISPUM WHOLE1WZA4Y92EXACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
URTICA DIOICA WHOLE710FLW4U46ACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
SUS SCROFA TESTICLEKM02613O28ACTIB
SUS SCROFA PITUITARY GLANDL0PFEMQ1DTACTIB
SUS SCROFA PROSTATEO6UD3347K2ACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
JUNIPERUS VIRGINIANA TWIG532BCG080LACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
Endoplex MAGNUS CASTUS, ARALIA QUINQUEFOLIA, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, SABAL SERRULATA, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, PULSATILLA (VULGARIS), GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, ORCHITINUM (SUIS), PROSTATE (SUIS), CLEMATIS ERECTA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc344a27cb-f15e-4a9f-87f4-c2627f02db772024-10-17WarningsExact identifier
ndc (package): 43857-0508-1
ndc (product): 43857-0508
ndc11 (package): 43857050801
spl id: 7f928117-dbc5-4ac2-8225-d21d894dd389
spl set id: 344a27cb-f15e-4a9f-87f4-c2627f02db77

Reported adverse events (FAERS/openFDA)#

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