FDA.reportPublic FDA data

Prostazen

Manufacturer
HCBIOPHARM LLC
Effective date
2026-03-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:38:13

Label at a glance#

ProductProstazen
Active ingredientSAW PALMETTO, RUBIA CORDIFOLIA ROOT, REYNOUTRIA JAPONICA ROOT
Label structure9 sections

Dosage and administration

Take two (2) capsules twice a day.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Reynoutria japonica Root 1X, Rubia cordifolia Root 1X, Saw Palmetto 1X

Purpose

OTC - PURPOSE SECTION

Reverses enlarged prostate, restores prostatic utricle function, and reverses prostatitis*

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Take two (2) capsules twice a day.

Use

INDICATIONS & USAGE SECTION

  • To reverse enlarged prostate
  • To restore prostatic utricle function
  • To reverse prostatitis

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Goji Berry (Lycium chinense) Fruit, Chinese Asparagus (Asparagus cochinchinensis), Eucommia (Eucommia ulmoides) Bark, Asiatic Plantain (Plantago asiatica), Cinnamon

Warning

WARNINGS SECTION

Individuals with known medical conditions should consult a doctor prior to using this.

Other Information

OTHER SAFETY INFORMATION

  • Do not use if seal is broken.
  • Do not eat freshness packet enclosed.
  • Keep product out of direct sunlight, high temperature, and humidity.
  • Store in a cool, dry place.

Package Label Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prostazen™

ENLARGED PROSTATE RECOVERY
PROSTATIC UTRICLE FUNCTION RESTORE
PROSTATITIS RECOVERY

Homeopathic 60 Capsules

prostazenprostazen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80353-702-01Prostazen1 in 1 BOXCAPSULE16
80353-702-02Prostazen1 in 1 BOTTLECAPSULE16
80353-702-03Prostazen60 in 1 CAPSULECAPSULE606

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80353-70280353-702-03, 80353-702-02, 80353-702-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAW PALMETTOJ7WWH9M8QSACTIB
LYCIUM CHINENSE FRUITTG711Q7A1QIACT
PLANTAGO ASIATICA5F5728J5E8IACT
ASPARAGUS COCHINCHINENSIS WHOLE36L6R7F7P9IACT
EUCOMMIA ULMOIDES BARKL878N1L0ARIACT
CINNAMON5S29HWU6QBIACT
RUBIA CORDIFOLIA ROOT4V873H15CGACTIB
REYNOUTRIA JAPONICA ROOT7TRV45YZF7ACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProstazenENLARGED PROSTATE, PROSTATIC UTRICLE FUNCTION, AND PROSTATITIS RECOVERYHCBIOPHARM LLCd16bc0cb-b9a6-9a24-e053-2995a90a7cd42026-03-30WarningsExact identifier
ndc (package): 80353-702-01
ndc (package): 80353-702-03
ndc (package): 80353-702-02
ndc (product): 80353-702
ndc11 (package): 80353070201
ndc11 (package): 80353070203
ndc11 (package): 80353070202
spl id: 4e38e5b2-1fc2-dfcb-e063-6294a90a3dc8
spl set id: d16bc0cb-b9a6-9a24-e053-2995a90a7cd4

Reported adverse events (FAERS/openFDA)#

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