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 3 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Private Label Distributor	LOPERAMIDE HCL 2 MG	Unifirst First Aid Corporation	069e7979-a223-4819-b6cf-ea2731bf156b	2025-12-01	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	American Health Packaging	42989f90-8ff5-44d1-a462-28c18ce02738	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3310a3c2-389a-4b27-a478-67c905789854	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	580e6cd4-3f05-4996-9dc3-c50d757ae210	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	9cf77219-c98d-487a-a5d3-61ceda6c65f5	2025-10-01	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	76a976d5-8bee-4158-a94d-7fbfc5544fd4	2025-09-23	Warnings	Name fallback brand name: Imodium A-D generic name: LOPERAMIDE HYDROCHLORIDE
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	01da76d0-1979-4c45-9d39-c72ae4e4ffe2	2025-09-23	Warnings	Name fallback brand name: Imodium A-D generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3f031dfb-be55-5a44-e063-6394a90aeec5	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Major Pharmaceuticals	1be585e2-ef49-4210-8a2d-22a326e4cc1b	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	A-S Medication Solutions	97c37571-9116-40d6-ba07-f4a5a8d9b689	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Institutional Inc.	ad71d4ab-d293-47a2-8f3f-2c9f42d76e40	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
CareOne Diarrhea Control	LOPERAMIDE HYDROCHLORIDE	American Sales Company	95ba9c92-77f5-4344-a4f3-78eda9ebc823	2025-07-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
basic care loperamide hydrochloride	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	f8a3b34a-ee08-466e-ab5f-475f1c2873ec	2025-07-17	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Precision Dose, Inc.	ae8237f0-95a6-4163-b476-25c0509ef151	2025-06-27	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Up and Up anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Target Corporation	ddb70e85-168e-451a-ac04-f6a46721a557	2025-06-02	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35a938af-decf-5b5d-e063-6294a90a9ab0	2025-05-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35aa2daf-3486-7ee2-e063-6394a90ad473	2025-05-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Albertsons Companies	1d4ec76d-ff0d-a55d-e063-6294a90ae22c	2025-04-07	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	86d94804-ad01-4106-8f23-033f3a6bab9e	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Redpharm Drug Inc	f4c23673-056e-7608-e053-2995a90a9276	2025-01-23	Warnings	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