FDA.reportPublic FDA data

NativeRemedies® Tranqui-Bladder™ Oral Spray

Manufacturer
Silver Star Brands | King Bio
Effective date
2016-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:12

Label at a glance#

ProductTranqui-Bladder
Active ingredientLILIUM LANCIFOLIUM WHOLE, STRYCHNOS NUX-VOMICA WHOLE, THUJA OCCIDENTALIS WHOLE, EQUISETUM HYEMALE, CAUSTICUM
Label structure10 sections

Indications and uses

For temporary relief of symptoms of an overactive or irritable bladder. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Dosage and administration

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 time daily. Use additionally as needed or until symptoms improve. Adults: Take 3 pump sprays. Children under 12: Take 2 pump sprays.

Label contents#

Full prescribing information#

HPUS Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in 30C potency: Causticum hyemale, Lilium tigrinum, Nux vomica, Thuja occidentalis.

Uses*:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms of an overactive or irritable bladder.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

WARNINGS SECTION

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 time daily. Use additionally as needed or until symptoms improve. Adults: Take 3 pump sprays. Children under 12: Take 2 pump sprays.

OTHER SAFETY INFORMATION

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For mroe information, visit us at www.nativeremedies.com

Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, potassium sorbate, purified water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Temporarily relieves occasional urgency & frequency

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tranqui-BladderTranqui-Bladder

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-263-022020-01-31C16284748780-19d75b9d1-11c7-f424-e053-dadaa90a57ceNativeRemedies® Tranqui-Bladder™ Oral Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-263-02Tranqui-Bladder59 mL in 1 BOTTLE, SPRAYSPRAY591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-263TRANQUI-BLADDER (CAUSTICUM, EQUISETUM HYEMALE, LILIUM TIGRINUM, NUX VOMICA, THUJA OCCIDENTALIS) SPRAY [SILVER STAR BRANDS]1Legacy NDC, 1 package rows20161024_3f29faae-66c2-1888-e054-00144ff88e88.zip

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
68703-26368703-263-02

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
LILIUM LANCIFOLIUM WHOLE079XQO23D9ACTIB
STRYCHNOS NUX-VOMICA WHOLEAB2NX17POSACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
THUJA OCCIDENTALIS WHOLE5HBV6WCE3NACTIM
EQUISETUM HYEMALE59677RXH25ACTIB
CAUSTICUMDD5FO1WKFUACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT
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
3f29faae-66c3-1888-e054-00144ff88e883f29faae-66c2-1888-e054-00144ff88e882016-10-18WarningsExact identifier
spl id: 3f29faae-66c3-1888-e054-00144ff88e88
spl set id: 3f29faae-66c2-1888-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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