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 3 of 43 · 845 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Anti-DiarrhealLOPERAMIDE HCLDOLGENCORP, LLC78814c22-5be2-45ee-b0be-977844746fcc2026-08-18WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLRedpharm Drug594b9c93-488a-0df0-e063-6394a90a2e992026-08-18WarningsExact identifier
unii: 77TI35393C
CVS Health Anti gasSIMETHICONECVS PHARMACY352b1d0e-c6dc-491e-b3e2-c3d9dac3213b2026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Infant Gas ReliefSIMETHICONECVS PHARMACY088993c1-31f0-4270-a3df-a585e7c8d5112026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEStrides Pharma, Inc.4178b3cc-e1ca-4912-8b1f-eac0110a39402026-08-13WarningsExact identifier
unii: 77TI35393C
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEYYBA CORP568064c9-139d-7233-e063-6294a90a10d42026-08-10WarningsExact identifier
unii: 77TI35393C
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEREMEDYREPACK INC.3fdfc0e5-56a2-48a0-8ee6-390a194a29f32026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
unii: 92RU3N3Y1O
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HCLAmazon.com Services LLC4dd99233-4fb0-41e2-8e0d-af102f00eefa2026-08-05WarningsExact identifier
unii: 77TI35393C
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
unii: 92RU3N3Y1O
INFANTS GAS RELIEF DROPSSIMETHICONERELIABLE 1 LABORATORIESb479bf22-3469-7916-e053-2995a90addc82026-07-30WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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