FDA.reportPublic FDA data

Gallbladder Sarcode

Manufacturer
Nutritional Specialties, Inc.
Effective date
2023-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:01

Label at a glance#

ProductGallbladder Sarcode
Active ingredientMILK THISTLE, CHELIDONIUM MAJUS WHOLE, ATROPA BELLADONNA, VERONICASTRUM VIRGINICUM ROOT, BOS TAURUS GALLBLADDER, BEEF LIVER, CITRULLUS COLOCYNTHIS FRUIT PULP, CHOLESTEROL
Label structure9 sections

Dosage and administration

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Carduus Marianus 3X, Chelidonium Majus 3X, Belladonna 4X, Leptandra Virginica 5X, Gallbladder 6X, Hepar (Liver) 6X, Colocynthis 7X, Cholesterinum 8X.

PURPOSE:

OTC - PURPOSE SECTION

Provides specific sarcode support for the gallbladder.†

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

WARNINGS:

WARNINGS SECTION

Professional Use Only

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

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Provides specific sarcode support for the gallbladder.†

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0096-1

GALLBLADDER

SARCODE

2 FL. OZ (60 ml)

GALLBLADDER SARCODEGALLBLADDER SARCODE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0096-1Gallbladder Sarcode60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0096GALLBLADDER SARCODE (CARDUUS MARIANUS, CHELIDONIUM MAJUS, BELLADONNA, LEPTANDRA VIRGINICA, GALLBLADDER (BOVINE), HEPAR (BOVINE), COLOCYNTHIS, CHOLESTERINUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230815_4174f3cf-5eb4-48d2-945d-b1de10bf7731.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-009683027-0096-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
VERONICASTRUM VIRGINICUM ROOTM2O62YTN42ACTIB
BOS TAURUS GALLBLADDER9901V1E867ACTIB
BEEF LIVERW8N8R55022ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
CHOLESTEROL97C5T2UQ7JACTIB
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
Gallbladder SarcodeCARDUUS MARIANUS, CHELIDONIUM MAJUS, BELLADONNA, LEPTANDRA VIRGINICA, GALLBLADDER (BOVINE), HEPAR (BOVINE), COLOCYNTHIS, CHOLESTERINUMNutritional Specialties, Inc.4174f3cf-5eb4-48d2-945d-b1de10bf77312023-08-14WarningsExact identifier
ndc (package): 83027-0096-1
ndc (product): 83027-0096
ndc11 (package): 83027009601
spl id: ef2b4f53-55db-4fd5-b745-4a4c3d597e21
spl set id: 4174f3cf-5eb4-48d2-945d-b1de10bf7731

Reported adverse events (FAERS/openFDA)#

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