FDA.reportPublic FDA data

Gallbladder Sarcode

Product NDC
83027-0096
11-digit product format
830270096
Labeler code
83027
Product ID
83027-0096_ef2b4f53-55db-4fd5-b745-4a4c3d597e21
Type
HUMAN OTC DRUG
Nonproprietary name
Carduus Marianus, Chelidonium Majus, Belladonna, Leptandra Virginica, Gallbladder (Bovine), Hepar (Bovine), Colocynthis, Cholesterinum
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-08-14
Substance
ATROPA BELLADONNA; BEEF LIVER; BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS WHOLE; CHOLESTEROL; CITRULLUS COLOCYNTHIS FRUIT PULP; MILK THISTLE; VERONICASTRUM VIRGINICUM ROOT
Active strength
4; 6; 6; 3; 8; 7; 3; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Gallbladder Sarcode
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILK THISTLE3 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
ATROPA BELLADONNA4 [hp_X]/mL
VERONICASTRUM VIRGINICUM ROOT5 [hp_X]/mL
BOS TAURUS GALLBLADDER6 [hp_X]/mL
BEEF LIVER6 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP7 [hp_X]/mL
CHOLESTEROL8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U946SH95EEInternal UNII lookup
7E889U5RNNInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
M2O62YTN42Internal UNII lookup
9901V1E867Internal UNII lookup
W8N8R55022Internal UNII lookup
23H32AOH17Internal UNII lookup
97C5T2UQ7JInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4174f3cf-5eb4-48d2-945d-b1de10bf7731Available on FDA.report

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

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 (product): 83027-0096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0096-18302700960160 mL in 1 BOTTLE, SPRAY (83027-0096-1) 60 ml2023-08-14NoNoCurrent