Anti Diarrheal

Product NDC: 37808-552
Requested package NDC: 37808-552-23
11-digit product format: 378080552
Labeler code: 37808
Product ID: 37808-552_27896be5-80e4-4821-8cbe-b1360b850e80
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H E B
Application: ANDA075232
Marketing category: ANDA
Marketing start: 2014-05-01
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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	37808-552	37808-552-23	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 · 9 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…`

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
A075232-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			2000-01-06

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	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Anti Diarrheal
Listing expiration: 2026-12-31

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
8ecbfd81-fe45-49b4-b835-a32192de8f53	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
37808-552-16	Anti Diarrheal	72 in 1 BOTTLE	TABLET, FILM COATED	72	6
37808-552-16	Anti Diarrheal	2 in 1 CARTON	TABLET, FILM COATED	2	6
37808-552-23	Anti Diarrheal	72 in 1 BOTTLE	TABLET, FILM COATED	72	6
37808-552-23	Anti Diarrheal	1 in 1 CARTON	TABLET, FILM COATED	1	6
37808-552-53	Anti Diarrheal	12 in 1 CARTON	TABLET, FILM COATED	12	6
37808-552-53	Anti Diarrheal	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	6
37808-552-67	Anti Diarrheal	1 in 1 CARTON	TABLET, FILM COATED	1	6
37808-552-67	Anti Diarrheal	48 in 1 BOTTLE	TABLET, FILM COATED	48	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-552	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]	6	Current NDC, Legacy NDC, 8 package rows	20241204_8ecbfd81-fe45-49b4-b835-a32192de8f53.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 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	L. Perrigo Company	9c1d811d-f8d0-418c-aaf7-7b6477deea20	2026-05-20	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
berkley and jensen anti diarrheal	LOPERAMIDE HYDROCHLORIDE	BJWC	dc29a8e9-f916-49d2-b9a6-d2b4537d7b58	2026-05-08	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HCL	Walgreen Company	6e0dfbb3-6c58-40fc-83b4-09ee10576ae5	2026-03-01	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	803f492d-183d-423f-b05c-48f06dc9f2a5	2026-01-19	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	HyVee Inc	9434cefe-6b13-47c4-b2f7-b8d566c5a4ff	2026-01-13	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Northwind Health Company, LLC	db47cc0a-e301-0310-e053-2a95a90a7f5d	2026-01-01	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Publix Super Markets Inc	44773392-eac8-48b3-ae46-b27f5fe55d8d	2025-12-28	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
CareOne Diarrhea Control	LOPERAMIDE HCL	American Sales Company	17569b2c-38f9-43bd-87ac-eb82b64866e6	2025-12-17	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
topcare anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Topco Associates LLC	da347b47-d8a5-4cf9-9579-79e6fe57fed5	2025-12-13	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Major Pharmaceuticals	be8f1c7d-fd4e-48d4-80b0-1d92a2ba6a70	2025-12-06	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	01da76d0-1979-4c45-9d39-c72ae4e4ffe2	2025-09-23	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
Leader Anti Diarrheal	LOPERAMIDE HCL	Cardinal Health 110, LLC. dba Leader	9079a59b-a158-4e77-a104-547959f7ba78	2025-07-18	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
Up and Up anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Target Corporation	ddb70e85-168e-451a-ac04-f6a46721a557	2025-06-02	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Redpharm Drug Inc	f4c23673-056e-7608-e053-2995a90a9276	2025-01-23	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
Anti Diarrheal	LOPERAMIDE HCL	H E B	8ecbfd81-fe45-49b4-b835-a32192de8f53	2024-12-02	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232 ndc (package): 37808-552-23 ndc (product): 37808-552 ndc11 (package): 37808055223
dg health anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Dolgencorp, LLC	cac9e7e9-fb3a-497e-866d-347530ba4dfd	2024-11-11	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
injoy diarrhea relief	LOPERAMIDE HCL	L. Perrigo Company	cf5ccdf8-ab27-429f-a1b4-c51ced021046	2024-08-12	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Meijer Distribution Inc	06a0530b-b06a-466b-b366-82a2a9f7c05c	2024-06-19	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
foster and thrive anti diarrheal	LOPERAMIDE HCL	Strategic Sourcing Services LLC	6f70564a-4400-4ed0-960b-09135a2f3a7c	2023-12-07	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	CVS Pharmacy	d8a55fb6-bb57-42d6-8e20-67fc91f38097	2023-10-13	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232

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	8ecbfd81-fe45-49b4-b835-a32192de8f53	6
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	8ecbfd81-fe45-49b4-b835-a32192de8f53	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-552-23	37808055223	1 BOTTLE in 1 CARTON (37808-552-23) > 72 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2014-05-01	0000-00-00	No	No	Current