Antidiarrheal Relief

Product NDC: 0498-1071
11-digit product format: 004981071
Labeler code: 0498
Product ID: 0498-1071_f0ec2740-9a35-1880-e053-2995a90a0bef
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: TABLET
Route: ORAL
Labeler: Honeywell Safety Products USA, Inc
Application: ANDA074091
Marketing category: ANDA
Marketing start: 2013-04-29
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0498-1071		D	Discontinued by firm		2026-08-03
excluded package	package	0498-1071	0498-1071-07	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0498-1071-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0498-1071-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0498-1071-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0498-1071-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0498-1071-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0498-1071-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0498-1071-07	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0498-1071-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0498-1071-07	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0498-1071-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0498-1071-07	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0498-1071-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074091-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			1992-12-10

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ANTIDIARRHEAL RELIEF (LOPERAMIDE HCL) TABLET [NORTH SAFETY PRODUCTS LLC]	1

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	eb93a17e-7daf-4a9e-94a1-442039a383bd	2026-06-26	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	ac674e5a-94df-4a35-9854-4e66cc17e509	2026-04-24	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Private Label Distributor	LOPERAMIDE HCL 2 MG	Unifirst First Aid Corporation	069e7979-a223-4819-b6cf-ea2731bf156b	2025-12-01	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	9cf77219-c98d-487a-a5d3-61ceda6c65f5	2025-10-01	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Medline Industries, LP	03d68bcf-6413-4fe3-8263-39cc315452d2	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal	LOPERAMIDE HCI	Lil' Drug Store Products, Inc.	eec84fa1-262f-6e77-e053-2995a90a325b	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal, Circle K	LOPERAMIDE HCL TABLET	Lil' Drug Store Products, Inc.	d3aaad65-f4cd-5eb0-e053-2995a90ade84	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal, Caseys 4good	LOPERAMIDE HCL	Lil' Drug Store Products, Inc.	043b0ab4-8fba-37d1-e063-6394a90a4cd4	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Lil Drug Store Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	fc23b13e-3005-4f23-aec2-b02a0e48ea11	2024-11-27	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Consortium, LLC	b070896b-1e22-41d4-a66d-8d3be1699217	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Zee Medical Inc	07e1f89c-5bf6-4539-848a-4435e7deb0d2	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Ohm Laboratories Inc.	c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Discount Drug Mart	6bc9771d-09f8-47ce-bbbd-8dd9aae97693	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Marc Glassman, Inc.	01efdce1-25ce-45ff-aeb6-f6fba00e59aa	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Valu Merchandisers Company	33335063-49a9-4e08-9d77-4cd80e94f021	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Fred's Inc.	a3bf91ae-22f3-4402-b73c-de026f2d0475	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	237b845b-0f02-410d-9750-c95123e6142d	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Handy Solutions Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76e32e66-4af5-47a5-83ff-cbba206975d6	2023-03-15	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	82e65393-25b7-4114-9c71-5840ee8bad84	2022-05-02	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0498-1071-07	00498107107	100 PACKET in 1 CARTON (0498-1071-07) > 1 TABLET in 1 PACKET (0498-1071-00)	100 packet	2018-11-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0498-1071: Antidiarrheal	Honeywell Safety Products USA, Inc \| OHM LABORATORIES INC.	2024-01-19	HUMAN OTC DRUG LABEL	8