FDA.reportPublic FDA data

Bladder Tone

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:45

Label at a glance#

ProductBladder Tone
Active ingredientATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, ARTEMISIA CINA PRE-FLOWERING TOP, EQUISETUM HYEMALE WHOLE, STRYCHNOS IGNATII SEED, PHYSALIS ALKEKENGI FRUIT, PULSATILLA PRATENSIS WHOLE, SEPIA OFFICINALIS JUICE, VERBASCUM THAPSUS WHOLE
Label structure9 sections

Dosage and administration

Adults and children over 12: Spray twice under the tongue 3 times per day. Children 12 and under: Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each spray) 10% of Belladonna 200C, Cantharis 200C, Causticum 200C, Cina 6X, Equisetum Hyemale 3X, Ignatia Amara 200C, Physalis Alkekengi 6X, Pulsatilla (Pratensis) 12X, Sepia 200C, Verbascum Thapsus 6X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with abnormal bladder function.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If symptoms persist for more than 7 days, consult a doctor.

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

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: Spray twice under the tongue 3 times per day.

Children 12 and under: Consult a doctor prior to use.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with abnormal bladder function.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

DIST. BY LIDDELL LABORATORIES INC.

WOODBINE, IA 51579

WWW.LIDDELL.NET 1-800-460-7733

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS

LIDDELL LABORATORIES

EST. 1994

BLADDER TONE

HOMEOPATHIC

1.0 FL. OZ. (30 ml)

Bladder ToneBladder Tone

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0271-12024-11-04C16284748780-1d6a99b39-e45f-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0271-12024-01-30C16284748780-1d6a99b39-e45f-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0271-12022-04-19C16284748780-1d6a99b39-e45f-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0271-12022-01-28C16284748780-1d6a99b39-e45f-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0271-1Bladder Tone30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0271BLADDER TONE (BELLADONNA, CANTHARIS, CAUSTICUM, CINA, EQUISETUM HYEMALE, IGNATIA AMARA, PHYSALIS ALKEKENGI, PULSATILLA (PRATENSIS), SEPIA, VERBASCUM THAPSUS) SPRAY [LIDDELL LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20241105_4b64399b-31f8-418a-b27d-a0b7a05de5ec.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-027150845-0271-1

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
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CAUSTICUMDD5FO1WKFUACTIB
ARTEMISIA CINA PRE-FLOWERING TOP28M1820ACTACTIB
EQUISETUM HYEMALE WHOLE59677RXH25ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
PHYSALIS ALKEKENGI FRUIT2042VC712PACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
VERBASCUM THAPSUS WHOLEC9TD27U172ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 ToneBELLADONNA, CANTHARIS, CAUSTICUM, CINA, EQUISETUM HYEMALE, IGNATIA AMARA, PHYSALIS ALKEKENGI, PULSATILLA (PRATENSIS), SEPIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.4b64399b-31f8-418a-b27d-a0b7a05de5ec2024-11-04WarningsExact identifier
ndc (package): 50845-0271-1
ndc (product): 50845-0271
ndc11 (package): 50845027101
spl id: d9daf8ae-2073-4638-89c6-01cfd21ee4d9
spl set id: 4b64399b-31f8-418a-b27d-a0b7a05de5ec

Reported adverse events (FAERS/openFDA)#

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