FDA.reportPublic FDA data

PROSTATE HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2012-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:11

Label at a glance#

ProductPROSTATE 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 structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): 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

INDICATIONS & USAGE SECTION

USES: Temporarily relieves interrupted urine flow, painful, burning urination, &/or other symptoms related to prostate weakness.

WARNINGS SECTION

WARNING:

Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING< ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - DO NOT USE SECTION

OTHER INFORMATION: Tamper Seal: "Sealed for your protection."

Do not use if seal is broken or missing.

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

OTC - QUESTIONS SECTION

QUESTIONS AND COMMENTS?

MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600

LOT:

OTC - PURPOSE SECTION

USES: Temporarily relieves interrupted urine flow, painful, burning urination, &/or other symptoms related to prostate weakness.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0039-1

PROSTATE HP

Prostate Issues

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730002488

Image Of LabelImage Of Label

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
43406-0039-12019-11-27C16284748780-19855d018-e0f9-cd31-e053-dbdaa90ab51aPROSTATE HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0039-1PROSTATE HP30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0039PROSTATE HP (CLEMATIS 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) LIQUID [NATURAL CREATIONS, INC.]1Legacy NDC, 1 package rows20121213_25d1c3ab-92fe-4b1e-ae20-389f5c189922.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9F1
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF3711
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JV1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QS1
SELENIUMACTIVE INGREDIENTH6241UJ22B1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9F1
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF3711
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JV1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
MERCURIC CATIONACTIVE MOIETYED30FJ8Y421
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QS1
SELENIUMACTIVE MOIETYH6241UJ22B1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-003943406-0039-1

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 TOP396421SP9FACTIM
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIM
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIM
MERCURIC CHLORIDE53GH7MZT1RACTIM
PULSATILLA VULGARISI76KB35JEVACTIM
SAW PALMETTOJ7WWH9M8QSACTIM
SELENIUMH6241UJ22BACTIM
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIM
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIM
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIM
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
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %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
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 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
168c2935-de22-4a32-83d5-5b51d15e44f025d1c3ab-92fe-4b1e-ae20-389f5c1899222012-11-12WarningsExact identifier
spl id: 168c2935-de22-4a32-83d5-5b51d15e44f0
spl set id: 25d1c3ab-92fe-4b1e-ae20-389f5c189922

Reported adverse events (FAERS/openFDA)#

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