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 4 of 43 · 845 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCbe99224e-dd49-4628-a5bf-ed8469ffd4a42026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
unii: 92RU3N3Y1O
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
unii: 92RU3N3Y1O
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
unii: 92RU3N3Y1O
Best ChoiceSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)245504a6-d2fc-4e05-871b-bab03f34e1542026-07-17WarningsExact identifier
unii: 92RU3N3Y1O
Best Choice Extra StrengthSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)a41b2895-abbe-4cf1-9c42-0b5e902d298b2026-07-17WarningsExact identifier
unii: 92RU3N3Y1O
Best Choice Extra Strength Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)529d7da6-5997-41f5-bfb8-33d2bbdce78e2026-07-17WarningsExact identifier
unii: 92RU3N3Y1O
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Anti DiarrhealLOPERAMIDE HCLYyba Corpe3b0a274-8bf9-4d39-a805-97fecca607f62026-07-13WarningsExact identifier
unii: 77TI35393C
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
unii: 92RU3N3Y1O
Anti-DiarrhealLOPERAMIDE HCLWalgreen Company31f9b652-e9c9-46ed-a46c-22d30ad110042026-07-10WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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