Anti-Diarrheal

Product NDC: 41163-375
11-digit product format: 411630375
Labeler code: 41163
Product ID: 41163-375_6954acb7-91c1-491a-85a6-964d4a8d4077
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: TABLET
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: ANDA076497
Marketing category: ANDA
Marketing start: 2005-05-03
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41163-375	41163-375-44	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A076497-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			2003-06-10

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	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Anti-Diarrheal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
77TI35393C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978010	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f16e07f3-0efb-4451-adbb-e427f9abc7ae	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-375-02	Anti-Diarrheal	2 in 1 CARTON	TABLET	2	24
41163-375-02	Anti-Diarrheal	6 in 1 BLISTER PACK	TABLET	6	24
41163-375-08	Anti-Diarrheal	4 in 1 CARTON	TABLET	4	24
41163-375-08	Anti-Diarrheal	6 in 1 BLISTER PACK	TABLET	6	24
41163-375-44	Anti-Diarrheal	3 in 1 CARTON	TABLET	3	24
41163-375-44	Anti-Diarrheal	6 in 1 BLISTER PACK	TABLET	6	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-375-02	EA - Each	41163-375	060613ec-67d7-4e2a-9994-f13fc8b96266	1	2016-10-06
41163-375-08	EA - Each	41163-375	ec872628-1d13-46b7-bc90-547ba661a523	1	2016-06-14
41163-375-22	EA - Each	41163-375	d26cbdec-e730-459c-abe8-8245827f4608	1	2016-12-07
41163-375-44	EA - Each	41163-375	fb41a48c-ad00-4a54-a87d-dbe8aaa48556	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]	5
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]	5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-375	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]	22	Current NDC, Legacy NDC, 6 package rows	20240724_f16e07f3-0efb-4451-adbb-e427f9abc7ae.zip

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti Diarrheal	LOPERAMIDE HCL	Yyba Corp	e3b0a274-8bf9-4d39-a805-97fecca607f6	2026-07-13	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Walgreen Company	31f9b652-e9c9-46ed-a46c-22d30ad11004	2026-07-10	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-diarrheal	LOPERAMIDE HCL	L.N.K. International, Inc.	e34f5bbc-e43c-a69e-e94d-ebc319518204	2026-06-23	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Discount Drug Mart	91843b17-3c04-482c-a2ba-143193be1595	2026-06-08	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti Diarrheal	LOPERAMIDE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f93a1f1f-2233-4338-9643-1ba48bd000bc	2026-06-03	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Family Dollar Services Inc	769e7182-fa11-4645-8fca-657253f28d9c	2026-05-27	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	H E B	8f7fea50-70cf-4f9f-a655-30371e5b9d9f	2026-05-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti Diarrheal	LOPERAMIDE HCL	Chain Drug Marketing Association, Inc.	dd993f38-a31f-4739-9496-e14186a89053	2026-05-18	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	United Natural Foods, Inc. dba UNFI	f16e07f3-0efb-4451-adbb-e427f9abc7ae	2026-05-18	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 41163-375
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	IMO-GEN LABS LLC	1b5f2c7c-baf0-b213-e063-6394a90a25df	2026-04-21	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Valu Merchandisers Company	70a7f827-f5be-454f-99bf-a7fd1037694e	2026-04-21	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	WinCo Foods, LLC	3990279b-45ee-49cf-9ecf-9ce23731b59a	2026-04-17	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Heartland Pharma Co.	e360ba61-556a-4d7f-ab2e-2cb71656d868	2026-04-17	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Grocery Outlet	94279e1f-5d87-40ba-8b4b-56930fdc3e3a	2026-03-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Rite Aid Corporation	c6cc4ba7-0e7a-4dd6-a5cf-b7e16e1a6c75	2026-03-11	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti Diarrheal	LOPERAMIDE HCL	Wal-Mart Stores Inc	b480916e-6383-468d-9e3e-499efea92522	2026-01-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
ANTI-DIARRHEAL	LOPERAMIDE HCL	Advanced Rx LLC	148cb6b7-28e7-48e9-b464-f42daa90e5da	2025-11-04	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Better Living Brands, LLC	8d3ccda2-3886-4ff7-ad10-6440fc4da6bf	2025-10-28	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	L.N.K. International, Inc.	c03a9389-8b33-4ade-8ba0-8f303e161a08	2025-10-06	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
First Aid Direct Anti-Diarrheal	FIRST AID DIRECT ANTI-DIARRHEAL	Cintas Corp	942b5af1-835e-41dd-bf65-e5b68352aa46	2025-09-29	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978010	loperamide HCl 2 MG Oral Tablet	PSN	f16e07f3-0efb-4451-adbb-e427f9abc7ae	24
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	f16e07f3-0efb-4451-adbb-e427f9abc7ae	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-375-02	41163037502	2 BLISTER PACK in 1 CARTON (41163-375-02) / 6 TABLET in 1 BLISTER PACK	2 blister pack	2005-05-03	0000-00-00	No	No	Current
41163-375-08	41163037508	4 BLISTER PACK in 1 CARTON (41163-375-08) / 6 TABLET in 1 BLISTER PACK	4 blister pack	2005-05-03	0000-00-00	No	No	Current
41163-375-44	41163037544	3 BLISTER PACK in 1 CARTON (41163-375-44) > 6 TABLET in 1 BLISTER PACK	3 blister pack	2005-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equaline 44-375	United Natural Foods, Inc. dba UNFI \| LNK International, Inc.	2026-05-18	HUMAN OTC DRUG LABEL	24