Home NDC 50580-338-07 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 Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-338 IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [KENVUE BRANDS LLC] 21 Current NDC, Legacy NDC, 18 package rows 20241215_ecb91e47-2b0c-47c8-9256-4623d8bc825e.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dimethicone ACTIVE INGREDIENT 92RU3N3Y1O IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 Loperamide Hydrochloride ACTIVE INGREDIENT 77TI35393C IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 Dimethicone ACTIVE MOIETY 92RU3N3Y1O IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 Loperamide ACTIVE MOIETY 6X9OC3H4II IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 calcium phosphate, dibasic, dihydrate INACTIVE INGREDIENT O7TSZ97GEP IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 6 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP IMODIUM 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Claravie Skin Repair Cream DIMETHICONE Gentell LLC 596ae269-172e-aef5-e063-6394a90a4e2a 2026-08-19 Warnings Exact identifier unii: 92RU3N3Y1O Anti-Diarrheal LOPERAMIDE HCL DOLGENCORP, LLC 78814c22-5be2-45ee-b0be-977844746fcc 2026-08-18 Warnings Exact identifier unii: 77TI35393C Anti-Diarrheal LOPERAMIDE HCL Redpharm Drug 594b9c93-488a-0df0-e063-6394a90a2e99 2026-08-18 Warnings Exact identifier unii: 77TI35393C CVS Health Anti gas SIMETHICONE CVS PHARMACY 352b1d0e-c6dc-491e-b3e2-c3d9dac3213b 2026-08-17 Warnings Exact identifier unii: 92RU3N3Y1O CVS Health Infant Gas Relief SIMETHICONE CVS PHARMACY 088993c1-31f0-4270-a3df-a585e7c8d511 2026-08-17 Warnings Exact identifier unii: 92RU3N3Y1O Mylanta Fall Harvest Collection Spiced Apple Cider CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE Infirst Healthcare Inc. 5a6040ff-1779-3215-e063-6294a90aaab1 2026-08-15 Warnings Exact identifier unii: 92RU3N3Y1O Mylanta Fall Harvest Collection Pumpkin Spice CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE Infirst Healthcare Inc. 5a60a221-5b37-806e-e063-6394a90a5ccc 2026-08-15 Warnings Exact identifier unii: 92RU3N3Y1O CVS PHARMACY Extra Strength Gas Relief SIMETHICONE ANTIGAS CVS b0fc2f24-cd63-4bb2-b9bb-a73449bcc169 2026-08-13 Warnings Exact identifier unii: 92RU3N3Y1O Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Strides Pharma, Inc. 4178b3cc-e1ca-4912-8b1f-eac0110a3940 2026-08-13 Warnings Exact identifier unii: 77TI35393C CVS PHARMACY Extra Strength SIMETHICONE CVS 98db6216-897c-4cf6-a4b7-b913ae3a2496 2026-08-13 Warnings Exact identifier unii: 92RU3N3Y1O CVS PHARMACY Gas relief SIMETHICONE CVS c2a3a978-c957-4453-88b3-53f4e80a2465 2026-08-13 Warnings Exact identifier unii: 92RU3N3Y1O Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE YYBA CORP 568064c9-139d-7233-e063-6294a90a10d4 2026-08-10 Warnings Exact identifier unii: 77TI35393C WinCo FOODS Extra Strength Gas Relief SIMETHICONE WINCO FOODS, LLC e2caf17a-a807-47f6-ab85-8e15a4679db4 2026-08-07 Warnings Exact identifier unii: 92RU3N3Y1O Extra Strength Gas Relief SIMETHICONE Shield Pharmaceuticals Corp 55952af9-c3c1-452f-82c8-06f01dc4f0af 2026-08-07 Warnings Exact identifier unii: 92RU3N3Y1O LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE REMEDYREPACK INC. 3fdfc0e5-56a2-48a0-8ee6-390a194a29f3 2026-08-07 Boxed warning, Warnings, Adverse reactions Exact identifier unii: 77TI35393C AMAZON EXTRA STRENGTH SIMETHICONE AMAZON.COM SERVICES LLC 705489ce-ac7c-44a8-8298-ead19824582e 2026-08-06 Warnings Exact identifier unii: 92RU3N3Y1O LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HCL Amazon.com Services LLC 4dd99233-4fb0-41e2-8e0d-af102f00eefa 2026-08-05 Warnings Exact identifier unii: 77TI35393C Gencare-Gas Relief SIMETHICONE 180 MG PIONEER LIFE SCIENCES, LLC b7f2d5db-c1b7-4c01-8ee6-017e4b9f1425 2026-08-04 Warnings Exact identifier unii: 92RU3N3Y1O Simethicone SIMETHICONE Aphena Pharma Solutions - Tennessee, LLC da0cc98e-1692-405a-ab81-420d6f9df6de 2026-07-31 Warnings Exact identifier unii: 92RU3N3Y1O INFANTS GAS RELIEF DROPS SIMETHICONE RELIABLE 1 LABORATORIES b479bf22-3469-7916-e053-2995a90addc8 2026-07-30 Warnings Exact identifier unii: 92RU3N3Y1O
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.