Home NDC 50580-338-61 IMODIUM
Product NDC 50580-338
Requested package NDC 50580-338-61
11-digit product format 505800338
Labeler code 50580
Product ID 50580-338_598d9530-ac42-e032-e063-6394a90a1edc
Type HUMAN OTC DRUG
Nonproprietary name loperamide hydrochloride and dimethicone
Dosage form TABLET
Route ORAL
Labeler Kenvue Brands LLC
Application NDA021140
Marketing category NDA
Marketing start 2008-07-01
Substance LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Active strength 2; 125 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021140-001 IMODIUM MULTI-SYMPTOM RELIEF LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021140-001 IMODIUM MULTI-SYMPTOM RELIEF 2MG;125MG TABLET / ORAL RLD, RS 2000-11-30 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base IMODIUM
Brand name suffix Multi-Symptom Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 2 mg/1 DIMETHICONE 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 77TI35393C Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978001 Internal RxNorm lookup 1426827 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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
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
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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-338-61 50580033861 4 BLISTER PACK in 1 CARTON (50580-338-61) / 6 TABLET in 1 BLISTER PACK 4 blister pack 2019-06-24 0000-00-00 No No Current