Application 020606

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, CHEWABLE;ORAL	2MG;125MG	Yes	No

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
N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET, CHEWABLE / ORAL		RLD	1996-06-26

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	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020606-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET, CHEWABLE / ORAL	RLD	1996-06-26	`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	Name fallback brand name: IMODIUM Multi-Symptom Relief

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48033	SUPPL	2017-04-14
48010	SUPPL	2017-04-13
20763	SUPPL	2008-07-31
24176	SUPPL	2008-07-16
25311	SUPPL	2008-05-05
25310	SUPPL	2004-06-16
20762	ORIG	1997-06-25