FDA.reportPublic FDA data

Gallbladder Formula

Manufacturer
King Bio Inc.
Effective date
2012-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:56

Label at a glance#

ProductGallbladder Formula
Active ingredientBERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, SILYBUM MARIANUM SEED, CHELIDONIUM MAJUS, CHOLESTEROL, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, DIOSCOREA VILLOSA TUBER, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE
Label structure8 sections

Indications and uses

Uses for symptomatic relief of: indigestion, bloating, gas, abdominal discomforts after eating. Assists natural gall bladder function. Promotes flow of bile.

Dosage and administration

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adult Dose 3 pump sprays Children 2 - 12 years 2 pump sprays

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Barberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

Purpose

OTC - PURPOSE SECTION


Uses for symptomatic relief of:

  • Indigestion
  • bloating
  • gas
  • abdominal discomforts after eating
Assists natural gall bladder function.
Promotes flow of bile.

Warnings

WARNINGS SECTION

If symptoms persist or worsen, consult a physician. If pregnant or nursing, take only on advice of healthcare professional. Keep out of reach of children.

Other: Tamper resistant for your protection. Use only if safety seal is intact.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION


Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed.

Adult Dose 3 pump sprays

Children 2 - 12 years 2 pump sprays

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for symptomatic relief of: indigestion, bloating, gas, abdominal discomforts after eating.

Assists natural gall bladder function.

Promotes flow of bile.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of label
Image of label

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-6058-22020-01-31C16284748780-19d75b9cf-ed74-f424-e053-dadaa90a57ceGallbladder Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-6058-2Gallbladder Formula59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-6058GALLBLADDER FORMULA (BARBER VULGARIS, BRYONIA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHOLESTERINUM, CINCHONA OFFICINALIS, COLOCYNTHIS, DIOSCOREA VILLOSA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20120906_25c008e1-ce66-4efc-83b9-dc3ebd64380d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0U1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN1
CHOLESTEROLACTIVE INGREDIENT97C5T2UQ7J1
CINCHONA OFFICINALIS BARKACTIVE INGREDIENTS003A158SB1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH171
DIOSCOREA VILLOSA TUBERACTIVE INGREDIENTIWY3IWX2G81
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EE1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0U1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN1
CHOLESTEROLACTIVE MOIETY97C5T2UQ7J1
CINCHONA OFFICINALIS BARKACTIVE MOIETYS003A158SB1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH171
DIOSCOREA VILLOSA TUBERACTIVE MOIETYIWY3IWX2G81
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EE1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-605857955-6058-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
SILYBUM MARIANUM SEEDU946SH95EEACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CHOLESTEROL97C5T2UQ7JACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
DIOSCOREA VILLOSA TUBERIWY3IWX2G8ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM SULFATE0YPR65R21JACTIB
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
249d7977-e03f-4f00-a65f-256573272c3725c008e1-ce66-4efc-83b9-dc3ebd64380d2012-09-05WarningsExact identifier
spl id: 249d7977-e03f-4f00-a65f-256573272c37
spl set id: 25c008e1-ce66-4efc-83b9-dc3ebd64380d

Reported adverse events (FAERS/openFDA)#

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