NDC 50580-338-50 - 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
50580-338-50
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 1 of 44 · 871 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEYYBA CORP5a728c6d-26ec-3316-e063-6394a90ade082026-09-09WarningsExact identifier
unii: 77TI35393C
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
rxcui: 978001
unii: 77TI35393C
unii: 92RU3N3Y1O
anti diarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacyd8a55fb6-bb57-42d6-8e20-67fc91f380972026-09-04WarningsExact identifier
unii: 77TI35393C
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra Strength Gas ReliefSIMETHICONE ANTIGASKROGER COMPANY6aa691e4-3179-4cf7-855a-e44f16904c1c2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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