Prostatone

Product NDC
43857-0492
11-digit product format
438570492
Labeler code
43857
Product ID
43857-0492_47cfa6d2-2a00-4198-a437-bf0f4fc39d52
Type
HUMAN OTC DRUG
Nonproprietary 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)
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-08-29
Substance
CLEMATIS 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 HEPTAHYDRATE
Active strength
12; 3; 5; 12; 4; 12; 3; 3; 3; 8; 8; 3 [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
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEMATIS RECTA FLOWERING TOP12 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
GOLDENSEAL5 [hp_X]/mL
PHOSPHORIC ACID12 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT4 [hp_X]/mL
PULSATILLA VULGARIS WHOLE12 [hp_X]/mL
SAW PALMETTO3 [hp_X]/mL
SMILAX ORNATA ROOT3 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]/mL
SUS SCROFA PROSTATE8 [hp_X]/mL
SUS SCROFA TESTICLE8 [hp_X]/mL
ZINC SULFATE HEPTAHYDRATE3 [hp_X]/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0492-1Prostatone30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0492PROSTATONE (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)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20250403_5f3f74e3-3772-4642-82bd-45c77a21a5c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0492-14385704920130 mL in 1 BOTTLE, DROPPER (43857-0492-1) 30 ml2018-08-290000-00-00NoNoCurrent