FDA.reportPublic FDA data

Prostex

Product NDC
44911-0288
11-digit product format
449110288
Labeler code
44911
Product ID
44911-0288_620b3f9c-06e0-4e24-8f86-9d9eb42dd075
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; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA PRATENSIS WHOLE; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prostex
Brand name suffix
HP
Listing expiration
2026-12-31

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
DELPHINIUM STAPHISAGRIA SEED30 [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
THUJA OCCIDENTALIS LEAFY TWIG30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6P669D8HQ8, 396421SP9F, Q28R5GF371, 00543AP1JV, C88X29Y479, 53GH7MZT1R, 8E272251DI, J7WWH9M8QS, H6241UJ22B, QDL83WN8C2, 1NT28V9397

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:
44911-0288-12023-01-30C16284748780-1ba0f9c33-1b8c-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:

DailyMed Package Descriptions#

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

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

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