Anti-Diarrheal

Product NDC: 41520-520
11-digit product format: 415200520
Labeler code: 41520
Product ID: 41520-520_358c89ad-4c0b-4288-b729-088840a0d3fe
Type: HUMAN OTC DRUG
Nonproprietary name: LOPERAMIDE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Care One (American Sales Company)
Application: NDA021855
Marketing category: NDA
Marketing start: 2010-08-05
Marketing end: 2025-05-30
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41520-520		D	Discontinued by firm		2026-10-12
excluded package	package	41520-520	41520-520-12	D	Discontinued by firm		2026-10-12

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-520-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-520-12	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021855-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL		RLD	2005-08-04
N021855-002	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL		RLD, RS	2005-08-04

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
GLYCERYL CAPRYLATE	INACTIVE INGREDIENT	TM2TZD4G4A	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-520	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	7	Legacy NDC	20221122_057c724e-f03e-4120-8cd1-ae58104e1c21.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	edae1ea7-7a6a-4971-8a21-c2b508e96f4e	2022-12-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
WELMATE Anti Diarrheal Loperamide HCl Softgels	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	ae2e15e9-1707-296d-e053-2995a90a1b95	2022-11-01	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DOLGENCORP, LLC	d1fd9a92-9d96-4921-b789-c1f710ee2351	2022-06-03	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Rite Aid Corporation	9cee17ca-bd11-3d40-e053-2995a90ac8fe	2022-05-24	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Strategic Sourcing Services LLC	1537febf-2816-438b-979a-8c8f16f06de5	2022-05-24	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	HEB	3ea49be2-1744-4d14-bc43-09d35fd4b3c7	2022-05-19	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	AMERISOURCE BERGEN	1a8f6a42-e74f-4725-b12e-b85c2d015191	2022-03-16	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	8f1ee652-a4f7-4e5b-874f-46aa641cd43f	2019-09-09	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855

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
41520-520-12	41520052012	1 BLISTER PACK in 1 CARTON (41520-520-12) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2010-08-05	2025-05-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide HCl 2 mg D	Care One (American Sales Company) \| P & L Development, LLC	2022-11-21	HUMAN OTC DRUG LABEL	7