FDA.reportPublic FDA data

Prostoforce

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:44

Label at a glance#

ProductProstoforce
Active ingredientAMERICAN GINSENG, TURNERA DIFFUSA LEAFY TWIG, CENTELLA ASIATICA WHOLE, SAW PALMETTO, THUJA OCCIDENTALIS LEAFY TWIG, CHONDRODENDRON TOMENTOSUM ROOT, CLEMATIS RECTA FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, JUNIPERUS VIRGINIANA TWIG, PULSATILLA VULGARIS WHOLE
Label structure9 sections

Indications and uses

For temporary relief of pain down thighs during efforts to urinate; great straining and constant urging when urinating.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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

Aralia Quinquefolia 3X, Clematis Erecta 12X, Conium Maculatum 12X, Damiana 3X, Hydrocotyle Asiatica 3X, Juniperus Virginiana 12X, Pareira Brava 8X, Pulsatilla 12X, Sabal Serrulata 3X, Thuja Occidentalis 3X.

PURPOSE:

OTC - PURPOSE SECTION

Aralia Quinquefolia – low back pain,** Clematis Erecta – painful urination,** Conium Maculatum - weak urine stream,** Damiana – hormonal support,** Hydrocotyle Asiatica – nervous debility,** Juniperus Virginiana – painful urination,** Pareira Brava – frequent urination,** Pulsatilla – kidney support,** Sabal Serrulata – overactive bladder,** Thuja Occidentalis – burning w/urination**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of pain down thighs during efforts to urinate; great straining and constant urging when urinating.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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

PROSTOFORCE

HOMEOPATHIC

1 fl. oz. (30 mL)

PROSTOFORCEPROSTOFORCE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810184340270GTIN-13: 0810184340270
EAN-13: 0810184340270
GTIN-12: 810184340270
UPC-A: 810184340270
GTIN storage (14 digits): 00810184340270		BANI0214 Prostoforce 6-20-25.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0560-12024-10-18C16284748780-1d6a99b39-8c1f-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0560-12022-01-28C16284748780-1d6a99b39-8c1f-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0560-1Prostoforce30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-056043857-0560-1

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
AMERICAN GINSENG8W75VCV53QACTIB
TURNERA DIFFUSA LEAFY TWIGRQ2CFA7WWJACTIB
CENTELLA ASIATICA WHOLE7M867G6T1UACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
CHONDRODENDRON TOMENTOSUM ROOT395A3P448ZACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
JUNIPERUS VIRGINIANA TWIG532BCG080LACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
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
ProstoforceARALIA QUINQUEFOLIA, DAMIANA, HYDROCOTYLE ASIATICA, SABAL SERRULATA, THUJA OCCIDENTALIS, PAREIRA BRAVA, CLEMATIS ERECTA, CONIUM MACULATUM, JUNIPERUS VIRGINIANA, PULSATILLA (VULGARIS)BioActive Nutritional, Inc.151fe63b-0dbd-4553-a29b-59af54014dbd2025-12-11WarningsExact identifier
ndc (package): 43857-0560-1
ndc (product): 43857-0560
ndc11 (package): 43857056001
spl id: 43734b28-869a-4fe6-b188-6ff57ff88c34
spl set id: 151fe63b-0dbd-4553-a29b-59af54014dbd

Reported adverse events (FAERS/openFDA)#

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