Bile Acids Combination

Product NDC
63083-9319
Requested package NDC
63083-9319-1
11-digit product format
630839319
Labeler code
63083
Product ID
63083-9319_298326d6-fa06-4c93-b738-89dddf3b6684
Type
HUMAN OTC DRUG
Nonproprietary name
Bile Acids Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
AMARYLLIS BELLADONNA WHOLE; CHELIDONIUM MAJUS WHOLE; BOS TAURUS BILE; BILIRUBIN
Active strength
10; 10; 10; 14 [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
Bile Acids Combination
Brand name suffix
9319
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMARYLLIS BELLADONNA WHOLE10 [hp_X]/29.5mL
CHELIDONIUM MAJUS WHOLE10 [hp_X]/29.5mL
BOS TAURUS BILE10 [hp_X]/29.5mL
BILIRUBIN14 [hp_X]/29.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11B89M58UNInternal UNII lookup
7E889U5RNNInternal UNII lookup
ET3651ZLOUInternal UNII lookup
RFM9X3LJ49Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aeca1d0e-4476-418f-ae46-f1055609659bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2026-01-08R319
2026-01-08R319
2024-01-30R319
2024-01-30R319

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9319-1Bile Acids Combination931929.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9319BILE ACIDS COMBINATION 9319 (BILE ACIDS COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_aeca1d0e-4476-418f-ae46-f1055609659b.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
Bile Acids Combination 9319BILE ACIDS COMBINATIONProfessional Complementary Health Formulasaeca1d0e-4476-418f-ae46-f1055609659b2026-01-08WarningsExact identifier
ndc (package): 63083-9319-1
ndc (product): 63083-9319
ndc11 (package): 63083931901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9319-16308393190129.5 mL in 1 BOTTLE, DROPPER (63083-9319-1) 29.5 ml1985-08-150000-00-00NoNoCurrent