Prostex

Product NDC
44911-0288
11-digit product format
449110288
Labeler code
44911
Product ID
44911-0288_d51aaf32-6f62-454c-9aa4-e79bcdb18b57
Type
HUMAN OTC DRUG
Nonproprietary name
Baryta Carbonica, Clematis Erecta, Conium Maculatum, Lycopodium Clavatum, Mercurius Corrosivus, Pulsatilla (Pratensis), Sabal Serrulata, Selenium Metallicum, Sepia, Staphysagria, Thuja Occidentalis
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-28
Substance
BARIUM 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
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Prostex
Brand name suffix
HP
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BARIUM CARBONATE30 [hp_X]/mL
CLEMATIS RECTA FLOWERING TOP30 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP30 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_X]/mL
MERCURIC CHLORIDE30 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE30 [hp_X]/mL
SAW PALMETTO30 [hp_X]/mL
SELENIUM30 [hp_X]/mL
SEPIA OFFICINALIS JUICE30 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED30 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6P669D8HQ8Internal UNII lookup
396421SP9FInternal UNII lookup
Q28R5GF371Internal UNII lookup
C88X29Y479Internal UNII lookup
53GH7MZT1RInternal UNII lookup
8E272251DIInternal UNII lookup
J7WWH9M8QSInternal UNII lookup
H6241UJ22BInternal UNII lookup
QDL83WN8C2Internal UNII lookup
00543AP1JVInternal UNII lookup
1NT28V9397Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56138252-bc94-41a7-815f-66bab5673a37Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2023-08-22DRUG FACTS:
2023-08-22DRUG FACTS:
2023-01-30DRUG FACTS:
2023-01-30DRUG FACTS:
2021-11-19DRUG FACTS:
2021-11-19DRUG FACTS:
2021-01-29DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0288-1ProstexHP30 mL in 1 BOTTLE, DROPPERLIQUID307

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BARIUM CARBONATEACTIVE INGREDIENT6P669D8HQ8PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9FPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF371PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JVPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1RPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
PULSATILLA PRATENSISACTIVE INGREDIENT8E272251DIPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QSPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
SELENIUMACTIVE INGREDIENTH6241UJ22BPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V9397PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
BARIUM CATIONACTIVE MOIETYV645272HLNPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9FPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF371PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JVPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
MERCURIC CATIONACTIVE MOIETYED30FJ8Y42PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QSPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
SELENIUMACTIVE MOIETYH6241UJ22BPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V9397PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0288PROSTEX HP (BARYTA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (PRATENSIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]7Current NDC, Legacy NDC, 1 package rows20230823_56138252-bc94-41a7-815f-66bab5673a37.zip

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 (product): 44911-0288

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0288-14491102880130 mL in 1 BOTTLE, DROPPER (44911-0288-1) 30 ml2015-10-280000-00-00NoNoCurrent