FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-08-29 01:01:13

Label at a glance#

ProductProstex HP
Active ingredientBARIUM CARBONATE, CLEMATIS RECTA FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, PULSATILLA PRATENSIS WHOLE, SAW PALMETTO, SELENIUM, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEED, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 9.09% of Baryta Carbonica 30X, 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

May temporarily relieve symptoms such as difficult urination, frequent urination at night, and dribbling of urine.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms such as difficult urination, frequent urination at night, and dribbling of urine.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
PROSTEX HP
1 fl. oz. (30 ml)

PROSTEX HPPROSTEX HP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363113701548GTIN-13: 0363113701548
EAN-13: 0363113701548
GTIN-12: 363113701548
UPC-A: 363113701548
GTIN storage (14 digits): 00363113701548		ENRG0737 Prostex HP 1oz 8-13-26.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0288-12023-08-22C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0288-12023-08-22C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0288-12023-01-30C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0288-12023-01-30C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0288-12021-11-19C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0288-12021-11-19C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0288-12021-01-29C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0288-12021-01-29C16284748780-1ba0f9c33-1b8c-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BARIUM CARBONATEACTIVE INGREDIENT6P669D8HQ82
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9F2
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF3712
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JV2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4792
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R2
PULSATILLA PRATENSISACTIVE INGREDIENT8E272251DI2
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QS2
SELENIUMACTIVE INGREDIENTH6241UJ22B2
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C22
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93972
BARIUM CATIONACTIVE MOIETYV645272HLN2
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9F2
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF3712
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JV2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4792
MERCURIC CATIONACTIVE MOIETYED30FJ8Y422
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QS2
SELENIUMACTIVE MOIETYH6241UJ22B2
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C22
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93972
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-028844911-0288-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BARIUM CARBONATE6P669D8HQ8ACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SELENIUMH6241UJ22BACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72023-08-22full-release2026-06-01 02:22:05

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
Prostex HPBARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISEnergique, Inc.56138252-bc94-41a7-815f-66bab5673a372026-08-26WarningsExact identifier
ndc (package): 44911-0288-1
ndc (product): 44911-0288
ndc11 (package): 44911028801
spl id: d51aaf32-6f62-454c-9aa4-e79bcdb18b57
spl set id: 56138252-bc94-41a7-815f-66bab5673a37

Reported adverse events (FAERS/openFDA)#

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