43857-0492 NDC - PROSTATONE (ECHINACEA (ANGUSTIFOLIA), SABAL SERRULATA, SARSAPARILLA (SMILAX REGELII), SOLIDAGO VIRGAUREA, ZINCUM SULPHURICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ORCHITINUM (SUIS), PROSTATE (SUIS), CLEMATIS ERECTA, PHOSPHORICUM ACIDUM, PULSATILLA (VULGARIS))

Drug Information

  • Product NDC: 43857-0492
  • Proprietary Name: Prostatone
  • Non Proprietary Name: Echinacea (Angustifolia), Sabal Serrulata, Sarsaparilla (Smilax Regelii), Solidago Virgaurea, Zincum Sulphuricum, Phytolacca Decandra, Hydrastis Canadensis, Orchitinum (Suis), Prostate (Suis), Clematis Erecta, Phosphoricum Acidum, Pulsatilla (Vulgaris)
  • Active Ingredient(s): 12 [hp_X]/mL CLEMATIS RECTA FLOWERING TOP; 3 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE; 5 [hp_X]/mL GOLDENSEAL; 12 [hp_X]/mL PHOSPHORIC ACID; 4 [hp_X]/mL PHYTOLACCA AMERICANA ROOT; 12 [hp_X]/mL PULSATILLA VULGARIS WHOLE; 3 [hp_X]/mL SAW PALMETTO; 3 [hp_X]/mL SMILAX ORNATA ROOT; 3 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP; 8 [hp_X]/mL SUS SCROFA PROSTATE; 8 [hp_X]/mL SUS SCROFA TESTICLE; 3 [hp_X]/mL ZINC SULFATE HEPTAHYDRATE
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Copper Absorption Inhibitor [EPC]; Decreased Copper Ion Absorption [PE]

Labeler Information

Field Name Field Value
Labeler Name: BioActive Nutritional, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/29/2018

Package Information

No. Package Code Package Description Billing Unit
143857-0492-130 mL in 1 BOTTLE, DROPPER (43857-0492-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43857-0492The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEProstatoneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEEchinacea (Angustifolia), Sabal Serrulata, Sarsaparilla (Smilax Regelii), Solidago Virgaurea, Zincum Sulphuricum, Phytolacca Decandra, Hydrastis Canadensis, Orchitinum (Suis), Prostate (Suis), Clematis Erecta, Phosphoricum Acidum, Pulsatilla (Vulgaris)The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/29/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEBioActive Nutritional, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS WHOLE; SAW PALMETTO; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; ZINC SULFATE HEPTAHYDRATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH12; 3; 5; 12; 4; 12; 3; 3; 3; 8; 8; 3 
ACTIVE INGRED UNIT[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; [hp_X]/mL 
PHARM CLASSESCopper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] 

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This page was last updated on: 11/21/2025

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