FDA.reportPublic FDA data

Kidney - Bladder

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:39

Label at a glance#

ProductKidney - Bladder
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 Oil, Arctostaphylos Uva-ursi Leaf, Echinacea, Unspecified, Goldenseal, Arctium Lappa Root, Solidago Virgaurea Flowering Top
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Apis mel. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Cinchona 15x, Equisetum hyem. 15x, Ferrum phos. 15x, Gelsemium 15x, Juniperus com. 15x, Pareira 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Sabal 15x, Terebinthina 15x, Uva-ursi 15x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-8006-12020-01-31C16284748780-19d75b9d0-a825-f424-e053-dadaa90a57ceKidney - Bladder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-8006-1Kidney - Bladder29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-8006KIDNEY - BLADDER (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.]1Legacy NDC, 1 package rows20140429_1fa8b352-ef0b-57e0-ffac-2928287adfbb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arctium Lappa RootACTIVE INGREDIENT597E9BI3Z31
Arctostaphylos Uva-ursi LeafACTIVE INGREDIENT3M5V3D1X361
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Chondrodendron Tomentosum RootACTIVE INGREDIENT395A3P448Z1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Equisetum HyemaleACTIVE INGREDIENT59677RXH251
Ferrosoferric PhosphateACTIVE INGREDIENT91GQH8I5F71
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Juniper BerryACTIVE INGREDIENTO84B5194RL1
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Plantago MajorACTIVE INGREDIENTW2469WNO6U1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Saw PalmettoACTIVE INGREDIENTJ7WWH9M8QS1
Solidago Virgaurea Flowering TopACTIVE INGREDIENT5405K23S501
Turpentine OilACTIVE INGREDIENTC5H0QJ6V7F1
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arctium Lappa RootACTIVE MOIETY597E9BI3Z31
Arctostaphylos Uva-ursi LeafACTIVE MOIETY3M5V3D1X361
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Chondrodendron Tomentosum RootACTIVE MOIETY395A3P448Z1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Equisetum HyemaleACTIVE MOIETY59677RXH251
Ferrosoferric PhosphateACTIVE MOIETY91GQH8I5F71
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
GoldensealACTIVE MOIETYZW3Z11D0JV1
Juniper BerryACTIVE MOIETYO84B5194RL1
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT1
PhosphorusACTIVE MOIETY27YLU75U4W1
Plantago MajorACTIVE MOIETYW2469WNO6U1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Saw PalmettoACTIVE MOIETYJ7WWH9M8QS1
Solidago Virgaurea Flowering TopACTIVE MOIETY5405K23S501
Turpentine OilACTIVE MOIETYC5H0QJ6V7F1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-800655714-8006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
Turpentine OilC5H0QJ6V7FACTIB
Arctostaphylos Uva-ursi Leaf3M5V3D1X36ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
GoldensealZW3Z11D0JVACTIB
Arctium Lappa Root597E9BI3Z3ACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates

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
ae43f96a-4c53-d83a-ae99-c83f70586cac1fa8b352-ef0b-57e0-ffac-2928287adfbb2014-04-15WarningsExact identifier
spl id: ae43f96a-4c53-d83a-ae99-c83f70586cac
spl set id: 1fa8b352-ef0b-57e0-ffac-2928287adfbb

Reported adverse events (FAERS/openFDA)#

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