Prostatone

Product NDC
43857-0392
11-digit product format
438570392
Labeler code
43857
Product ID
43857-0392_3fd3c753-54a6-43d8-a998-53a6f7f74870
Type
HUMAN OTC DRUG
Nonproprietary name
Clematis Erecta, Conium Maculatum, Lycopodium Clavatum, Mercurius Corrosivus, Pulsatilla (Vulgaris), Sabal Serrulata, Selenium Metallicum, Sepia, Staphysagria, Thuja Occidentalis
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-04-26
Substance
CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
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 VULGARIS30 [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
Unii396421SP9F, Q28R5GF371, 00543AP1JV, C88X29Y479, 53GH7MZT1R, I76KB35JEV, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0392-1ProstatoneHP30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0392PROSTATONE HP (CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC]2Current NDC, Legacy NDC, 1 package rows20250406_2ccf602f-734a-4b2d-8d89-c410293f9eb9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0392-14385703920130 mL in 1 BOTTLE, DROPPER (43857-0392-1) 30 ml2016-04-260000-00-00NoNoCurrent