FDA.reportPublic FDA data

Application 021140

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMODIUM MULTI-SYMPTOM RELIEFLOPERAMIDE HYDROCHLORIDE; SIMETHICONETABLET;ORAL2MG;125MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021140-001IMODIUM MULTI-SYMPTOM RELIEFLOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORALRLD, RS2000-11-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021140-001IMODIUM MULTI-SYMPTOM RELIEF2MG;125MGTABLET / ORALRLD, RS2000-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021140-001IMODIUM MULTI-SYMPTOM RELIEF2MG;125MGTABLET / ORALRLD, RS2000-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021140-001IMODIUM MULTI-SYMPTOM RELIEF2MG;125MGTABLET / ORALRLD, RS2000-11-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021140-001IMODIUM MULTI-SYMPTOM RELIEF2MG;125MGTABLET / ORALRLD, RS2000-11-30a50c72e98297…

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
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
application applno (NDA): 021140
application number: NDA021140
ndc (product): 50580-338

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50580-338IMODIUMloperamide hydrochloride and dimethiconeJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-338IMODIUMloperamide hydrochloride and dimethiconeJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-338IMODIUMloperamide hydrochloride and dimethiconeJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-338IMODIUMloperamide hydrochloride and dimethiconeJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-338IMODIUMloperamide hydrochloride and dimethiconeJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-338IMODIUMloperamide hydrochloride and dimethiconeJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-338IMODIUMloperamide hydrochloride and dimethiconeJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56812SUPPL2018-12-20
56725SUPPL2018-12-13
48032SUPPL2017-04-14
48009SUPPL2017-04-13
36203SUPPL2015-03-24
4445SUPPL2015-03-19
26888SUPPL2012-05-08
21471SUPPL2008-07-31
44638SUPPL2008-07-16
26886SUPPL2008-05-05
26887SUPPL2008-02-07
4444SUPPL2007-09-25
36202SUPPL2007-09-19
4443SUPPL2004-06-16
36201SUPPL2004-06-07
4442SUPPL2004-06-07
26885ORIG2000-11-29
14482ORIG2000-11-29
21470ORIG2000-01-29