Prostatone

Product NDC
43857-0137
11-digit product format
438570137
Labeler code
43857
Product ID
43857-0137_85ac187a-e130-4480-811a-cdb85fc1639a
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Sabal Serrulata, Sarsaparilla, Solidago Virgaurea
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-02-27
Marketing end
2020-08-25
Substance
ECHINACEA, UNSPECIFIED; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; SAW PALMETTO; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ZINC SULFATE HEPTAHYDRATE; SUS SCROFA TESTICLE; SUS SCROFA PROSTATE; CLEMATIS RECTA FLOWERING TOP; PHOSPHORIC ACID; PULSATILLA VULGARIS
Active strength
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
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43857-0137DDiscontinued by firm2026-10-05
excluded packagepackage43857-013743857-0137-1DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43857-0137-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43857-0137-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43857-0137-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43857-0137-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43857-0137-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43857-0137-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43857-0137-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43857-0137-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43857-0137-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43857-0137-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43857-0137-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43857-0137-1557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9FPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ECHINACEA, UNSPECIFIEDACTIVE INGREDIENT4N9P6CC1DXPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JVPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NNPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEGPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QSPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SMILAX REGELII ROOTACTIVE INGREDIENT2H1576D5WGPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S50PROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA PROSTATEACTIVE INGREDIENTO6UD3347K2PROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA TESTICLEACTIVE INGREDIENTKM02613O28PROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ZINC SULFATE HEPTAHYDRATEACTIVE INGREDIENTN57JI2K7WPPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9FPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ECHINACEA, UNSPECIFIEDACTIVE MOIETY4N9P6CC1DXPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GOLDENSEALACTIVE MOIETYZW3Z11D0JVPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NNPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEGPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SARSAPARILLAACTIVE MOIETY2H1576D5WGPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QSPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S50PROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA PROSTATEACTIVE MOIETYO6UD3347K2PROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA TESTICLEACTIVE MOIETYKM02613O28PROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37PROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROSTATONE (ECHINACEA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, SABAL SERRULATA, SARSAPARILLA, SOLIDAGO VIRGAUREA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1