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 4 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	f3ea8779-252e-4038-ae41-500e15c54825	2025-01-22	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	AvPAK	f8992723-dd9a-bcf6-e053-6294a90aa65c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Medline Industries, LP	03d68bcf-6413-4fe3-8263-39cc315452d2	2024-12-29	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DISCOUNT DRUG MART, INC.	ed28814d-9733-46ff-930f-b148e31f2f51	2024-12-23	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	KROGER COMPANY	ff5dcb48-318c-4f2a-8df2-73ff6dd2a49e	2024-12-23	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Lil Drug Store Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	fc23b13e-3005-4f23-aec2-b02a0e48ea11	2024-11-27	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
dg health anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Dolgencorp, LLC	cac9e7e9-fb3a-497e-866d-347530ba4dfd	2024-11-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	A-S Medication Solutions	d572ecf7-ddc3-46fb-80a6-80b7b1b90a1b	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Safeway	9d0c565f-64a2-4300-b1e2-5dee9546ea14	2024-10-22	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	NorthStar Rx LLC	858c2b62-98e6-46d7-9253-9b3a00040a4e	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	17035ff7-8ba8-131c-e063-6394a90af5ea	2024-10-03	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	865cf4c7-f643-451b-b0d4-d30bda621f7d	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1adb7a28-9dc6-3f8b-e063-6394a90a9335	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3e898141-8d40-49f1-e054-00144ff88e88	2024-08-13	Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Advanced Rx LLC	287bd6d9-aa29-4f56-9c7f-5cbacbf62537	2024-08-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	f245e8f4-e06e-492e-8c46-af1fce1633fc	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	af0b886f-c065-26dc-e053-2995a90ac471	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Meijer Distribution Inc	06a0530b-b06a-466b-b366-82a2a9f7c05c	2024-06-19	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CARDINAL HEALTH	bd58d6e9-628c-4c6b-b44c-da95e0417ba7	2024-05-31	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	10edd7bc-fc35-abe3-e063-6394a90aeb3f	2024-05-15	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