Home NDC 43857-0392 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; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; 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 [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 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 Prostatone
Brand name suffix HP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLEMATIS RECTA FLOWERING TOP 30 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP 30 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 30 [hp_X]/mL MERCURIC CHLORIDE 30 [hp_X]/mL PULSATILLA VULGARIS 30 [hp_X]/mL SAW PALMETTO 30 [hp_X]/mL SELENIUM 30 [hp_X]/mL SEPIA OFFICINALIS JUICE 30 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED 30 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43857-0392-1 ProstatoneHP 30 mL in 1 BOTTLE, DROPPER LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0392 PROSTATONE HP (CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC] 2 Current NDC, Legacy NDC, 1 package rows 20250406_2ccf602f-734a-4b2d-8d89-c410293f9eb9.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prostatone HP CLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS BioActive Nutritional, Inc 2ccf602f-734a-4b2d-8d89-c410293f9eb9 2025-04-02 Warnings Exact identifier ndc (product): 43857-0392
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43857-0392-1 43857039201 30 mL in 1 BOTTLE, DROPPER (43857-0392-1) 30 ml 2016-04-26 0000-00-00 No No Current