Application 019860

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 A-D	LOPERAMIDE HYDROCHLORIDE	TABLET;ORAL	2MG	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
N019860-001	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL		RLD, RS	1989-11-22

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	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`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 2 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	IMO-GEN LABS LLC	1b5f2c7c-baf0-b213-e063-6394a90a25df	2026-04-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	04a35525-ae8e-b41e-e063-6294a90ab10e	2026-04-20	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	DOLGENCORP INC	4db35031-f765-39a6-e063-6394a90a40c9	2026-03-20	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Safecor Health LLC	8b0ac05b-90c1-476b-b001-5801dd21701d	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CVS Pharmacy, Inc.	60bc8f05-f35e-45e0-ba3b-c82a87d60f5b	2026-02-27	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Golden State Medical Supply, Inc.	396f7e13-b357-52be-e063-6394a90a92fc	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	803f492d-183d-423f-b05c-48f06dc9f2a5	2026-01-19	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	HyVee Inc	9434cefe-6b13-47c4-b2f7-b8d566c5a4ff	2026-01-13	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Advagen Pharma Ltd.,	03c907d5-87f8-47a6-9544-5a24f5272739	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Northwind Health Company, LLC	db47cc0a-e301-0310-e053-2a95a90a7f5d	2026-01-01	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Publix Super Markets Inc	44773392-eac8-48b3-ae46-b27f5fe55d8d	2025-12-28	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	31bfcbb4-c58c-4edc-ac68-356a448b7507	2025-12-22	Warnings	Name fallback brand name: Imodium A-D generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	d92819f1-d02d-4959-a019-17d44df6ed2f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	WALGREENS	50814751-8bee-4768-bf6c-e9da3400090b	2025-12-15	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
topcare anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Topco Associates LLC	da347b47-d8a5-4cf9-9579-79e6fe57fed5	2025-12-13	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	TARGET Corporation	ee8a6bdf-847e-4b88-8aea-6d3daa669994	2025-12-12	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	440fb3ce-4106-4169-b187-cfbfdd2f42c1	2025-12-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	45a1e6b0-1e2b-958a-e063-6394a90a261d	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Major Pharmaceuticals	be8f1c7d-fd4e-48d4-80b0-1d92a2ba6a70	2025-12-06	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Redpharm Drug	3b0ac1a9-ffa6-9af6-e063-6294a90a2678	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66715-9720	Imodium AD	Loperamide Hydrochloride	Lil' Drug Store Products, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57941	SUPPL	2019-03-08
57934	SUPPL	2019-03-08
48030	SUPPL	2017-04-14
48012	SUPPL	2017-04-13
1732	SUPPL	2012-05-08
41070	SUPPL	2008-07-31
19779	SUPPL	2004-06-16
1731	SUPPL	2001-04-11