Loperamide Hydrochloride

Product NDC: 68094-029
11-digit product format: 680940029
Labeler code: 68094
Product ID: 68094-029_73a0214b-3f58-4357-ab53-314111602166
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Precision Dose, Inc.
Application: ANDA091292
Marketing category: ANDA
Marketing start: 2020-05-18
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 1 mg/7.5mL
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loperamide Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	1 mg/7.5mL

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
1250685	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
ae8237f0-95a6-4163-b476-25c0509ef151	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
68094-029-59	Loperamide Hydrochloride	7.5 mL in 1 CUP, UNIT-DOSE	SOLUTION	7.5	4
68094-029-62	Loperamide Hydrochloride	3 in 1 CASE	SOLUTION	3	4
68094-029-62	Loperamide Hydrochloride	10 in 1 TRAY	SOLUTION	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-029-59	ML - Milliliter	68094-029	1c384854-615a-4dd0-ba25-ebf5feb0fa60	1	2020-06-05
68094-029-62	ML - Milliliter	68094-029	c7bd8b8e-d65f-41e7-985e-bb04b42f2f8e	1	2020-06-05

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 ndc (product): 68094-029
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250685	loperamide HCl 1 MG in 7.5 mL Oral Suspension	PSN	ae8237f0-95a6-4163-b476-25c0509ef151	4
1250685	loperamide hydrochloride 0.133 MG/ML Oral Suspension	SCD	ae8237f0-95a6-4163-b476-25c0509ef151	4
1250685	loperamide HCl 1 MG per 7.5 ML Oral Solution	SY	ae8237f0-95a6-4163-b476-25c0509ef151	4
1250685	loperamide hydrochloride 1 MG per 7.5 ML Oral Suspension	SY	ae8237f0-95a6-4163-b476-25c0509ef151	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-029-59	68094002959	7.5 mL in 1 CUP, UNIT-DOSE	7.5 ml					Historical
68094-029-62	68094002962	3 TRAY in 1 CASE (68094-029-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 7.5 mL in 1 CUP, UNIT-DOSE (68094-029-59)	3 tray	2020-05-18	0000-00-00	No	No	Current