CareOne Diarrhea Control

Product NDC: 41520-813
11-digit product format: 415200813
Labeler code: 41520
Product ID: 41520-813_9781fece-a022-4c74-b5ff-ea39a29b4b16
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Sales Company
Application: ANDA075232
Marketing category: ANDA
Marketing start: 2016-09-14
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	41520-813	41520-813-67	D	Discontinued by firm		2026-08-03

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: CareOne Diarrhea Control
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
17569b2c-38f9-43bd-87ac-eb82b64866e6	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
41520-813-53	CareOne Diarrhea Control	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5
41520-813-53	CareOne Diarrhea Control	12 in 1 CARTON	TABLET, FILM COATED	12	5
41520-813-62	CareOne Diarrhea Control	24 in 1 CARTON	TABLET, FILM COATED	24	5
41520-813-62	CareOne Diarrhea Control	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5
41520-813-67	CareOne Diarrhea Control	1 in 1 CARTON	TABLET, FILM COATED	1	5
41520-813-67	CareOne Diarrhea Control	48 in 1 BOTTLE	TABLET, FILM COATED	48	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-813	CAREONE DIARRHEA CONTROL (LOPERAMIDE HCL) TABLET, FILM COATED [AMERICAN SALES COMPANY]	4	Current NDC, Legacy NDC, 6 package rows	20200104_17569b2c-38f9-43bd-87ac-eb82b64866e6.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 ndc (product): 41520-813
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
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	17569b2c-38f9-43bd-87ac-eb82b64866e6	5
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	17569b2c-38f9-43bd-87ac-eb82b64866e6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-813-53	41520081353	12 BLISTER PACK in 1 CARTON (41520-813-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK	12 blister pack	2016-09-14	0000-00-00	No	No	Current
41520-813-62	41520081362	24 BLISTER PACK in 1 CARTON (41520-813-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK	24 blister pack	2016-09-14	0000-00-00	No	No	Current
41520-813-67	41520081367	1 BOTTLE in 1 CARTON (41520-813-67) > 48 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2016-09-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Diarrhea Control Drug Facts	American Sales Company	2025-12-17	HUMAN OTC DRUG LABEL	5