SP

Product NDC
52654-0003
Requested package NDC
52654-0003-1
11-digit product format
526540003
Labeler code
52654
Product ID
52654-0003_05096613-11bb-460f-95ca-cc4e79e980c8
Type
HUMAN OTC DRUG
Nonproprietary name
Brosimum Acutifolium, Himatanthus Sucuuba, Mansoa Alliacea, Minquartia Guianensis, Phyllanthus Niruri, Piper Aduncum
Dosage form
LIQUID
Route
ORAL
Labeler
Chi Research, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-05-18
Marketing end
2024-04-15
Substance
BROSIMUM ACUTIFOLIUM BARK; HIMATANTHUS LANCIFOLIUS BARK; MANSOA ALLIACEA BARK; MANSOA ALLIACEA LEAF; MINQUARTIA GUIANENSIS BARK; PHYLLANTHUS NIRURI WHOLE; PIPER ADUNCUM LEAF
Active strength
32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52654-000352654-0003-1DDiscontinued by firm2026-10-05

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 · 18 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52654-0003-12022-11-11C16284748780-19d75b9cf-e99f-f424-e053-dadaa90a57ceDrug Facts:
52654-0003-12020-01-31C16284748780-19d75b9cf-e99f-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROSIMUM ACUTIFOLIUM BARKACTIVE INGREDIENT8Q6X4504YCSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
HIMATANTHUS LANCIFOLIUS BARKACTIVE INGREDIENT8O169FEF9TSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
MANSOA ALLIACEA BARKACTIVE INGREDIENT2H997JHQ75SP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
MANSOA ALLIACEA LEAFACTIVE INGREDIENT63AYO2O03YSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
MINQUARTIA GUIANENSIS BARKACTIVE INGREDIENT8Q29UL9T9ZSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
PHYLLANTHUS NIRURI WHOLEACTIVE INGREDIENTNSN3MQO38GSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
PIPER ADUNCUM LEAFACTIVE INGREDIENT718MWR54QOSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
BROSIMUM ACUTIFOLIUM BARKACTIVE MOIETY8Q6X4504YCSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
HIMATANTHUS LANCIFOLIUS BARKACTIVE MOIETY8O169FEF9TSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
MANSOA ALLIACEA BARKACTIVE MOIETY2H997JHQ75SP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
MANSOA ALLIACEA LEAFACTIVE MOIETY63AYO2O03YSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
MINQUARTIA GUIANENSIS BARKACTIVE MOIETY8Q29UL9T9ZSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
PHYLLANTHUS NIRURI WHOLEACTIVE MOIETYNSN3MQO38GSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
PIPER ADUNCUM LEAFACTIVE MOIETY718MWR54QOSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSP (SPIRO COMPLEX) LIQUID [CHI RESEARCH, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52654-0003-152654000301120 mL in 1 BOTTLE, DROPPER (52654-0003-1) 120 ml2016-05-182024-04-15NoNoCurrent