loperamide hydrochloride

Product NDC: 0363-0645
Requested package NDC: 0363-0645-34
11-digit product format: 003630645
Labeler code: 0363
Product ID: 0363-0645_8aac3f97-448c-4bb9-a62e-0690071a48de
Type: HUMAN OTC DRUG
Nonproprietary name: loperamide HCl
Dosage form: SUSPENSION
Route: ORAL
Labeler: Walgreen Company
Application: ANDA091292
Marketing category: ANDA
Marketing start: 2012-05-18
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 1 mg/7.5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0363-0645	0363-0645-34	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0645	0363-0645-34	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0645	0363-0645-34	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0645-26	ML - Milliliter	0363-0645	a86441e1-a20e-40ab-8e44-7ecadf6828e9	1	2013-03-03
0363-0645-34	ML - Milliliter	0363-0645	24d685a3-16c9-4d8e-acd2-5b6348d66ac8	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0645	LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]	5	Legacy NDC	20180123_65abebcc-f5e2-4bd5-bf37-20e0fb53dc4c.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 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
loperamide hydrochloride	LOPERAMIDE HCL	Preferred Pharmaceuticals Inc.	0b1f8d41-51b3-4362-8de7-46bca5caff12	2026-05-28	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
loperamide hydrochloride	LOPERAMIDE HCL	Meijer Distribution Inc	5f693cf6-dced-425f-b25e-37a9f8ec17d6	2026-04-06	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
loperamide hydrochloride	LOPERAMIDE HCL	Major Pharmaceuticals	cf5dc855-f0cc-4d7e-8d15-472f7e654409	2026-02-13	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
Good Sense antidiarrheal	LOPERAMIDE HCL	Preferred Pharmaceuticals Inc.	672ca656-6abb-42d4-8dbc-9f3428c35058	2026-01-23	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
Equate Loperamide Hydrochloride	LOPERAMIDE HCL	Wal-Mart Stores Inc	d8efaddf-4c28-4a7d-af58-42850c7901cd	2026-01-19	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
Good Sense antidiarrheal	LOPERAMIDE HCL	L. Perrigo Company	9928de7e-c148-4a19-a946-d4af911c2631	2025-10-28	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
CareOne Diarrhea Control	LOPERAMIDE HYDROCHLORIDE	American Sales Company	95ba9c92-77f5-4344-a4f3-78eda9ebc823	2025-07-21	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
leader anti diarrheal	LOPERAMIDE HCL	Cardinal Health 110, LLC. dba Leader	f845fad8-6b3c-4c7e-94bc-d4f99f69e4f0	2025-07-21	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
basic care loperamide hydrochloride	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	f8a3b34a-ee08-466e-ab5f-475f1c2873ec	2025-07-17	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Precision Dose, Inc.	ae8237f0-95a6-4163-b476-25c0509ef151	2025-06-27	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
equate diarrhea control	LOPERAMIDE HCL	Wal-Mart Stores Inc	53283496-4e65-40ea-8dfb-851ea2c0cc15	2025-06-19	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
loperamide hydrochloride	LOPERAMIDE HCL	ATLANTIC BIOLOGICALS CORP.	7030f4ed-3cd1-428e-9cae-3b14933d41f5	2025-05-12	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
Up and Up anti diarrheal	LOPERAMIDE HCL	Target Corporation	2f5a9854-e1da-4835-9ca4-556a84428e2f	2025-04-12	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
leader anti diarrheal	LOPERAMIDE HCL	Cardinal Health 110, LLC. dba Leader	c27e6fbd-8822-4784-9d24-497ae78e54f4	2025-04-12	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
DG Health Anti Diarrheal	LOPERAMIDE HCL	Dolgencorp Inc	46e3046f-0aea-4848-b5ab-bac4ff0c7f2e	2025-04-12	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
foster and thrive anti-diarrheal	LOPERAMIDE HCL	Strategic Sourcing Services LLC	e2074a9b-2702-470c-9112-e67ef5e4905c	2025-04-12	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
equaline loperamide hydrochloride	LOPERAMIDE HCL	United Natural Foods, Inc. dba UNFI	9277f433-8b50-4b5b-bfe6-d257d89ebd90	2025-04-12	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
anti diarrheal	LOPERAMIDE HCL	Kroger Company	ff129e3b-6983-4c2f-8c99-dd0e6dc3870f	2025-04-11	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
Loperamide hydrochloride	LOPERAMIDE HCL	CVS Pharmacy	4c620875-1d8d-4170-be93-8649d9d99f4a	2025-04-11	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
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

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
0363-0645-34	00363064534	240 mL in 1 BOTTLE (0363-0645-34)	240 ml	2012-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreen Co. Loperamide Hydrochloride Oral Suspension Drug Facts	Walgreen Company	2017-12-19	HUMAN OTC DRUG LABEL	5