CareOne Diarrhea Control

Product NDC: 41520-767
11-digit product format: 415200767
Labeler code: 41520
Product ID: 41520-767_3cbd17c0-6e94-4d97-aafa-4da2ca0ea4ec
Type: HUMAN OTC DRUG
Nonproprietary name: loperamide HCl
Dosage form: SUSPENSION
Route: ORAL
Labeler: American Sales Company
Application: ANDA091292
Marketing category: ANDA
Marketing start: 2016-09-20
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 1 mg/7.5mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	41520-767		D	Discontinued by firm	2026-10-12
excluded package	package	41520-767	41520-767-26	D	Discontinued by firm	2026-10-12
excluded package	package	41520-767	41520-767-34	D	Discontinued by firm	2026-10-12

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
A091292-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL			2011-05-20

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2011-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2011-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2011-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2011-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-767	CAREONE DIARRHEA CONTROL (LOPERAMIDE HCL) SUSPENSION [AMERICAN SALES COMPANY]	4	Legacy NDC	20200206_b5b64564-cca1-4ca8-9606-c0e370315cb5.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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
anti diarrheal	LOPERAMIDE HCL	H E B	01964f8a-f05c-4f72-9530-e0cffd981ffa	2025-04-11	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
good neighbor pharmacy loperamide hydrochloride	LOPERAMIDE HCL	Amerisource Bergen	53f66b4a-b97b-4995-b2cf-e33afe996af1	2025-04-11	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
Anti Diarrheal	LOPERAMIDE HCL	Walgreen Company	f70d0568-27c0-4c63-8d68-82e31b87174f	2025-04-11	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
basic care loperamide hydrochloride	LOPERAMIDE HCL	Amazon.com Services LLC	d6b8015c-f8fe-45cb-891f-566fb319b46b	2025-04-03	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
topcare loperamide hydrochloride	LOPERAMIDE HCL	Topco Associates LLC	1cd497b4-d97e-447a-9251-710d2fddbf23	2025-04-01	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Safeway	9d0c565f-64a2-4300-b1e2-5dee9546ea14	2024-10-22	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
loperamide hydrochloride	LOPERAMIDE HCL	Rite Aid Corporation	56334ed4-8cb0-4f5c-9051-6836f0e21337	2024-06-28	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292

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
41520-767-26	41520076726	120 mL in 1 BOTTLE (41520-767-26)	120 ml	2016-09-20	0000-00-00	No	No	Current
41520-767-34	41520076734	240 mL in 1 BOTTLE (41520-767-34)	240 ml	2016-09-20	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	2020-02-05	HUMAN OTC DRUG LABEL	4