NDC 50580-338-07 - IMODIUM Multi-Symptom Relief

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50580-338
Requested NDC
50580-338-07
Package NDCs from labels
50580-338-12, 50580-338-18, 50580-338-42, 50580-338-30, 50580-338-60, 50580-338-61, 50580-338-64, 50580-338-06, 50580-338-07, 50580-338-52, 50580-338-51, 50580-338-50
Manufacturer
Kenvue Brands LLC
Effective date
2026-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IMODIUM Multi-Symptom Relief - Kenvue Brands LLCKenvue Brands LLC2026-08-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-338-06IMODIUMMulti-Symptom Relief6 in 1 BLISTER PACKTABLET623
50580-338-06IMODIUMMulti-Symptom Relief1 in 1 CARTONTABLET123
50580-338-07IMODIUMMulti-Symptom Relief6 in 1 BLISTER PACKTABLET623
50580-338-07IMODIUMMulti-Symptom Relief1 in 1 CARTONTABLET123
50580-338-12IMODIUMMulti-Symptom Relief2 in 1 CARTONTABLET223
50580-338-12IMODIUMMulti-Symptom Relief6 in 1 BLISTER PACKTABLET623
50580-338-18IMODIUMMulti-Symptom Relief3 in 1 CARTONTABLET323
50580-338-18IMODIUMMulti-Symptom Relief6 in 1 BLISTER PACKTABLET623
50580-338-30IMODIUMMulti-Symptom Relief30 in 1 BOTTLETABLET3023
50580-338-30IMODIUMMulti-Symptom Relief1 in 1 CARTONTABLET123
50580-338-42IMODIUMMulti-Symptom Relief42 in 1 BOTTLETABLET4223
50580-338-42IMODIUMMulti-Symptom Relief1 in 1 CARTONTABLET123
50580-338-60IMODIUMMulti-Symptom Relief1 in 1 CARTONTABLET123
50580-338-60IMODIUMMulti-Symptom Relief2 in 1 PACKAGETABLET223
50580-338-61IMODIUMMulti-Symptom Relief6 in 1 BLISTER PACKTABLET623
50580-338-61IMODIUMMulti-Symptom Relief4 in 1 CARTONTABLET423
50580-338-64IMODIUMMulti-Symptom Relief4 in 1 CARTONTABLET423
50580-338-64IMODIUMMulti-Symptom Relief6 in 1 BLISTER PACKTABLET623

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-338IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [KENVUE BRANDS LLC]21Current NDC, Legacy NDC, 18 package rows20241215_ecb91e47-2b0c-47c8-9256-4623d8bc825e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-338-12EA - Each50580-33898056e1f-993f-4dd8-a5dd-b63528eda74c12013-07-02
50580-338-18EA - Each50580-338a8d1002b-0f8b-42fc-acf9-b8ace53acdcf12013-07-02
50580-338-30EA - Each50580-338c686b314-ade6-4385-b915-3c115c5d9a2112013-07-02
50580-338-42EA - Each50580-3385d616fac-b4ee-4f71-9679-b2a20b4ef3ae12013-07-02
50580-338-61EA - Each50580-338d9877b44-8edd-4c7a-a250-52835559fbd312020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1OIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
Loperamide HydrochlorideACTIVE INGREDIENT77TI35393CIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
DimethiconeACTIVE MOIETY92RU3N3Y1OIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
LoperamideACTIVE MOIETY6X9OC3H4IIIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6
stearic acidINACTIVE INGREDIENT4ELV7Z65APIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]6

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 2 of 43 · 845 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurohealth LLCf9a53a23-a8ea-4521-8f0b-1bc2a658ff682026-08-28WarningsExact identifier
unii: 77TI35393C
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
rxcui: 978001
unii: 77TI35393C
unii: 92RU3N3Y1O
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
application number: NDA021140
ndc (package): 50580-338-60
ndc (package): 50580-338-51
ndc (package): 50580-338-12
ndc (package): 50580-338-42
ndc (package): 50580-338-61
ndc (package): 50580-338-50
ndc (package): 50580-338-07
ndc (package): 50580-338-64
ndc (package): 50580-338-18
ndc (package): 50580-338-06
ndc (package): 50580-338-30
ndc (package): 50580-338-52
ndc (product): 50580-338
ndc11 (package): 50580033807
rxcui: 978001
rxcui: 1426827
spl id: 598d9530-ac42-e032-e063-6394a90a1edc
spl set id: ecb91e47-2b0c-47c8-9256-4623d8bc825e
unii: 77TI35393C
unii: 92RU3N3Y1O
Loperamide HClLOPERAMIDE HCLDirect_Rx59e1c4cf-17cc-13c9-e063-6294a90af61c2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrhealLOPERAMIDE HCLCVS Pharmacy68467222-c8b4-4029-a180-59a57d0090d32026-08-19WarningsExact identifier
unii: 77TI35393C
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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