FDA.reportPublic FDA data

BioE Urinary

Manufacturer
BioEnergetics, Inc.
Effective date
2019-12-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:50:28

Label at a glance#

ProductBioE Urinary
Active ingredientAPIS MELLIFERA, SILVER NITRATE, BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, POPULUS TREMULOIDES WHOLE, ANEMONE PULSATILLA, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, DELPHINIUM STAPHISAGRIA SEED, ZINC
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Apis mel 6x, Argentum nit 9x, Berberis vulg 6x, Cantharis 6x, Populus tremuloides 6x, Pulsatilla 6x, Sabal serulata 6x, Solidago virg 6x, Staphysagria 9x, Zincum met 12x

Purpose

OTC - PURPOSE SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol 20%, purified water.

INDICATIONS & USAGE SECTION

Recommended for urinary discomfort.

These uses are based on traditional homeopathic practice. They have not been evauated by the FDA.

Dosage:

DOSAGE & ADMINISTRATION SECTION

In general, 10 drops under the tongue 3 times daily. In acute conditions, 10 drops every 15 minutes.  Children, one half the above dosage. For children 2 years and under, and for people nursing a baby or pregnant, seek the advice of a health professional before use.

WARNINGS SECTION

DO NOT USE

OTC - DO NOT USE SECTION

IF BioE IMPRINTED SEAL ON NECK IS BROKEN

OTC - STOP USE SECTION

If symptoms worsen or persist for more than 7 days, consult a physician.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioE UrinaryBioE Urinary

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57293-443057293-4430-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
APIS MELLIFERA7S82P3R43ZACTIB
SILVER NITRATE95IT3W8JZEACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
POPULUS TREMULOIDES WHOLEMUN0TBE4PEACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
ZINCJ41CSQ7QDSACTIB

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
d350601d-e5db-6f8a-e053-2995a90a82268dfd917e-e869-4a81-ae5a-4da7055eced22021-12-16WarningsExact identifier
spl set id: 8dfd917e-e869-4a81-ae5a-4da7055eced2

Reported adverse events (FAERS/openFDA)#

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