IMODIUM

Product NDC: 50580-338
Requested package NDC: 50580-338-42
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50580-338	50580-338-42	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ecb91e47-2b0c-47c8-9256-4623d8bc825e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-338-06	IMODIUMMulti-Symptom Relief	6 in 1 BLISTER PACK	TABLET	6	23
50580-338-06	IMODIUMMulti-Symptom Relief	1 in 1 CARTON	TABLET	1	23
50580-338-07	IMODIUMMulti-Symptom Relief	6 in 1 BLISTER PACK	TABLET	6	23
50580-338-07	IMODIUMMulti-Symptom Relief	1 in 1 CARTON	TABLET	1	23
50580-338-12	IMODIUMMulti-Symptom Relief	2 in 1 CARTON	TABLET	2	23
50580-338-12	IMODIUMMulti-Symptom Relief	6 in 1 BLISTER PACK	TABLET	6	23
50580-338-18	IMODIUMMulti-Symptom Relief	3 in 1 CARTON	TABLET	3	23
50580-338-18	IMODIUMMulti-Symptom Relief	6 in 1 BLISTER PACK	TABLET	6	23
50580-338-30	IMODIUMMulti-Symptom Relief	30 in 1 BOTTLE	TABLET	30	23
50580-338-30	IMODIUMMulti-Symptom Relief	1 in 1 CARTON	TABLET	1	23
50580-338-42	IMODIUMMulti-Symptom Relief	42 in 1 BOTTLE	TABLET	42	23
50580-338-42	IMODIUMMulti-Symptom Relief	1 in 1 CARTON	TABLET	1	23
50580-338-60	IMODIUMMulti-Symptom Relief	1 in 1 CARTON	TABLET	1	23
50580-338-60	IMODIUMMulti-Symptom Relief	2 in 1 PACKAGE	TABLET	2	23
50580-338-61	IMODIUMMulti-Symptom Relief	6 in 1 BLISTER PACK	TABLET	6	23
50580-338-61	IMODIUMMulti-Symptom Relief	4 in 1 CARTON	TABLET	4	23
50580-338-64	IMODIUMMulti-Symptom Relief	4 in 1 CARTON	TABLET	4	23
50580-338-64	IMODIUMMulti-Symptom Relief	6 in 1 BLISTER PACK	TABLET	6	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-338-12	EA - Each	50580-338	98056e1f-993f-4dd8-a5dd-b63528eda74c	1	2013-07-02
50580-338-18	EA - Each	50580-338	a8d1002b-0f8b-42fc-acf9-b8ace53acdcf	1	2013-07-02
50580-338-30	EA - Each	50580-338	c686b314-ade6-4385-b915-3c115c5d9a21	1	2013-07-02
50580-338-42	EA - Each	50580-338	5d616fac-b4ee-4f71-9679-b2a20b4ef3ae	1	2013-07-02
50580-338-61	EA - Each	50580-338	d9877b44-8edd-4c7a-a250-52835559fbd3	1	2020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IMODIUM Multi-Symptom Relief	LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE	Kenvue Brands LLC	ecb91e47-2b0c-47c8-9256-4623d8bc825e	2026-08-25	Warnings	Exact identifier application applno (NDA): 021140 application number: NDA021140 ndc (package): 50580-338-42 ndc (product): 50580-338 ndc11 (package): 50580033842

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1426827	Imodium Multi-Symptom Relief 2 MG / 125 MG Oral Tablet	PSN	ecb91e47-2b0c-47c8-9256-4623d8bc825e	23
978001	loperamide HCl 2 MG / simethicone 125 MG Oral Tablet	PSN	ecb91e47-2b0c-47c8-9256-4623d8bc825e	23
1426827	loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet [Imodium Multi-Symptom Relief]	SBD	ecb91e47-2b0c-47c8-9256-4623d8bc825e	23
978001	loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet	SCD	ecb91e47-2b0c-47c8-9256-4623d8bc825e	23
1426827	Imodium Multi-Symptom Relief (loperamide HCl 2 MG / simethicone 125 MG) Oral Tablet	SY	ecb91e47-2b0c-47c8-9256-4623d8bc825e	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-338-42	50580033842	1 BOTTLE in 1 CARTON (50580-338-42) > 42 TABLET in 1 BOTTLE	1 bottle	2008-07-01	0000-00-00	No	No	Current