FDA.reportPublic FDA data

Bladder - Kidney

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:13:35

Label at a glance#

ProductBladder - Kidney
Active ingredientAPIS MELLIFERA, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CINCHONA OFFICINALIS BARK, EQUISETUM HYEMALE, FERROSOFERRIC PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, JUNIPER BERRY, CHONDRODENDRON TOMENTOSUM ROOT, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA VULGARIS, SAW PALMETTO, TURPENTINE, ARCTOSTAPHYLOS UVA-URSI LEAF, ECHINACEA, UNSPECIFIED, GOLDENSEAL, ARCTIUM LAPPA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

WARNINGS SECTION

Warning:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net ~ Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hydrastis 6x, Lappa 6x, Solidago 6x., Apis mel. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Cinchona 15x, Equisetum hyemale 15x, Ferrum phos.15x, Gelsemium 15x, Juniperus com. 15x, Pareira 15x, Phosp. 15x, Plantago 15x, Pulsatilla 15x, Sabal 15x, Terebinthina 15x, Uva-ursi 15x.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

INDICATIONS & USAGE SECTION

Bladder - Kidney Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2388-0Bladder - Kidney0.5 mL in 1 BOTTLE, GLASSLIQUID0.55
55714-2388-1Bladder - Kidney30 mL in 1 BOTTLE, GLASSLIQUID305
55714-2388-2Bladder - Kidney50 mL in 1 BOTTLE, GLASSLIQUID505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2388BLADDER - KIDNEY (APIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGO) LIQUID [NEWTON LABORATORIES, INC.]5Current NDC, Legacy NDC, 3 package rows20201125_7965a320-2976-284f-e053-2991aa0a1529.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-238855714-2388-0, 55714-2388-1, 55714-2388-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
APIS MELLIFERA7S82P3R43ZACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
EQUISETUM HYEMALE59677RXH25ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
JUNIPER BERRYO84B5194RLACTIB
CHONDRODENDRON TOMENTOSUM ROOT395A3P448ZACTIB
PHOSPHORUS27YLU75U4WACTIB
PLANTAGO MAJORW2469WNO6UACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
TURPENTINEXJ6RUH0O4GACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GOLDENSEALZW3Z11D0JVACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
WATER059QF0KO0RIACT

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
Bladder - KidneyAPIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGONewton Laboratories, Inc.7965a320-2976-284f-e053-2991aa0a15292020-11-24WarningsExact identifier
ndc (package): 55714-2388-2
ndc (package): 55714-2388-1
ndc (package): 55714-2388-0
ndc (product): 55714-2388
ndc11 (package): 55714238802
ndc11 (package): 55714238801
ndc11 (package): 55714238800
spl id: b4de0dee-104c-e63f-e053-2995a90a7ba6
spl set id: 7965a320-2976-284f-e053-2991aa0a1529

Reported adverse events (FAERS/openFDA)#

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