Application 021140

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMODIUM MULTI-SYMPTOM RELIEF	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	TABLET;ORAL	2MG;125MG	Yes	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	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…`

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 (product): 50580-338

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-338	IMODIUM	loperamide hydrochloride and dimethicone	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-338	IMODIUM	loperamide hydrochloride and dimethicone	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-338	IMODIUM	loperamide hydrochloride and dimethicone	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-338	IMODIUM	loperamide hydrochloride and dimethicone	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-338	IMODIUM	loperamide hydrochloride and dimethicone	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-338	IMODIUM	loperamide hydrochloride and dimethicone	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-338	IMODIUM	loperamide hydrochloride and dimethicone	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56812	SUPPL	2018-12-20
56725	SUPPL	2018-12-13
48032	SUPPL	2017-04-14
48009	SUPPL	2017-04-13
36203	SUPPL	2015-03-24
4445	SUPPL	2015-03-19
26888	SUPPL	2012-05-08
21471	SUPPL	2008-07-31
44638	SUPPL	2008-07-16
26886	SUPPL	2008-05-05
26887	SUPPL	2008-02-07
4444	SUPPL	2007-09-25
36202	SUPPL	2007-09-19
4443	SUPPL	2004-06-16
36201	SUPPL	2004-06-07
4442	SUPPL	2004-06-07
26885	ORIG	2000-11-29
14482	ORIG	2000-11-29
21470	ORIG	2000-01-29