FDA.reportPublic FDA data

Gallbladder Drops

Product NDC
63083-5006
11-digit product format
630835006
Labeler code
63083
Product ID
63083-5006_3bc16151-f598-4f9d-93f5-f05576b7a4a6
Type
HUMAN OTC DRUG
Nonproprietary name
Gallbladder Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
AMARYLLIS BELLADONNA WHOLE; BEEF LIVER; BOS TAURUS BILE; BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS WHOLE; CHIONANTHUS VIRGINICUS BARK; CHOLESTEROL; CITRULLUS COLOCYNTHIS FRUIT PULP; MILK THISTLE; VERONICASTRUM VIRGINICUM WHOLE
Active strength
3; 6; 6; 6; 3; 3; 4; 6; 2; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gallbladder Drops 5006GALLBLADDER DROPSProfessional Complementary Health Formulasf07b10e1-00b1-47d7-b745-72165781c6d22026-01-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if you are experiencing severe abdominal or chest pain, or if accompanied by a fever. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Additional Listing Data#

Finished product
Yes
Brand name base
Gallbladder Drops
Brand name suffix
5006
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILK THISTLE3 [hp_X]/59mL
AMARYLLIS BELLADONNA WHOLE6 [hp_X]/59mL
CHELIDONIUM MAJUS WHOLE6 [hp_X]/59mL
CHIONANTHUS VIRGINICUS BARK6 [hp_X]/59mL
VERONICASTRUM VIRGINICUM WHOLE3 [hp_X]/59mL
CHOLESTEROL3 [hp_X]/59mL
CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]/59mL
BOS TAURUS BILE6 [hp_X]/59mL
BOS TAURUS GALLBLADDER2 [hp_X]/59mL
BEEF LIVER3 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU946SH95EE, 11B89M58UN, 7E889U5RNN, 1RA4P35F0I, 97C5T2UQ7J, 23H32AOH17, ET3651ZLOU, 9901V1E867, W8N8R55022

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-5006-22026-01-08C16284748780-11030e365-6292-111a-e063-dadaa90a10e2HGD
63083-5006-22026-01-08C16284748780-11030e365-6292-111a-e063-dadaa90a10e2HGD
63083-5006-22024-01-30C16284748780-11030e365-6292-111a-e063-dadaa90a10e2HGD
63083-5006-22024-01-30C16284748780-11030e365-6292-111a-e063-dadaa90a10e2HGD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-5006-2Gallbladder Drops500659 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-5006GALLBLADDER DROPS 5006 (GALLBLADDER DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_f07b10e1-00b1-47d7-b745-72165781c6d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-5006-26308350060259 mL in 1 BOTTLE, DROPPER (63083-5006-2) 59 ml1985-08-150000-00-00NoNoCurrent