Intestine Drops

Product NDC
63083-5009
Requested package NDC
63083-5009-2
11-digit product format
630835009
Labeler code
63083
Product ID
63083-5009_1b92a7de-ccee-4496-a3f8-9ff3b0cd9181
Type
HUMAN OTC DRUG
Nonproprietary name
Intestine Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
PLANTAGO LANCEOLATA LEAF; GENTIANA LUTEA ROOT; GOLDENSEAL; ULMUS RUBRA BARK; BOS TAURUS LARGE INTESTINE; SUS SCROFA PARASYMPATHETIC NERVE
Active strength
3; 5; 5; 6; 6; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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
Intestine Drops
Brand name suffix
5009
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PLANTAGO LANCEOLATA LEAF3 [hp_X]/59mL
GENTIANA LUTEA ROOT5 [hp_X]/59mL
GOLDENSEAL5 [hp_X]/59mL
ULMUS RUBRA BARK6 [hp_X]/59mL
BOS TAURUS LARGE INTESTINE6 [hp_X]/59mL
SUS SCROFA PARASYMPATHETIC NERVE30 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2YWL9J7EE8Internal UNII lookup
S72O3284MSInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
91QY4PXU8QInternal UNII lookup
D176AZC57OInternal UNII lookup
5AZZ2GHR69Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
51298670-06bb-4b17-a7e5-3efd91717c1aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-5009-2Intestine Drops500959 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-5009INTESTINE DROPS 5009 (INTESTINE DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_51298670-06bb-4b17-a7e5-3efd91717c1a.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
Intestine Drops 5009INTESTINE DROPSProfessional Complementary Health Formulas51298670-06bb-4b17-a7e5-3efd91717c1a2026-01-08WarningsExact identifier
ndc (package): 63083-5009-2
ndc (product): 63083-5009
ndc11 (package): 63083500902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-5009-26308350090259 mL in 1 BOTTLE, DROPPER (63083-5009-2) 59 ml1985-08-150000-00-00NoNoCurrent