FDA.reportPublic FDA data

Prostatone

Manufacturer
BioActive Nutritional, Inc | Apotheca Company
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:33:02

Label at a glance#

ProductProstatone HP
Active ingredientCLEMATIS RECTA FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, PULSATILLA VULGARIS, SAW PALMETTO, SELENIUM, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEED, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Indications and uses

For temporary relief of symptoms due to swelling and tenderness in the area of the prostate.

Dosage and administration

• 10 drops orally, 3 times a day. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Clematis Erecta 30X, Conium Maculatum 30X, Lycopodium Clavatum 30X, Mercurius Corrosivus 30X, Pulsatilla 30X, Sabal Serrulata 30X, Selenium Metallicum 30X, Sepia 30X, Staphysagria 30X, Thuja Occidentalis 30X.

PURPOSE:

OTC - PURPOSE SECTION

Clematis Erecta - itching,** Conium Maculatum - fatigue,** Lycopodium Clavatum – low libido,** Mercurius Corrosivus - inflammation,** Pulsatilla – urge to urinate,** Sabal Serrulata – painful urination,** Selenium Metallicum – low libido,** Sepia - impotence,** Staphysagria - itching,** Thuja Occidentalis – burning without urinations**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms due to swelling and tenderness in the area of the prostate.

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 a cool, dry place.

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

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

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

PROSTATONE HP

HOMEOPATHIC

1 FL OZ (30 ml)

Prostatone HPProstatone HP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0392-1ProstatoneHP30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0392PROSTATONE HP (CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC]2Current NDC, Legacy NDC, 1 package rows20250406_2ccf602f-734a-4b2d-8d89-c410293f9eb9.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-039243857-0392-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SELENIUMH6241UJ22BACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
Prostatone HPCLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISBioActive Nutritional, Inc2ccf602f-734a-4b2d-8d89-c410293f9eb92025-04-02WarningsExact identifier
ndc (package): 43857-0392-1
ndc (product): 43857-0392
ndc11 (package): 43857039201
spl id: 3fd3c753-54a6-43d8-a998-53a6f7f74870
spl set id: 2ccf602f-734a-4b2d-8d89-c410293f9eb9

Reported adverse events (FAERS/openFDA)#

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