Anti-Diarrheal

Product NDC: 70677-0060
11-digit product format: 706770060
Labeler code: 70677
Product ID: 70677-0060_dfc70da2-b6cc-23c1-e053-2995a90a33f1
Type: HUMAN OTC DRUG
Nonproprietary name: LOPERAMIDE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: STRATEGIC SOURCING SERVICES, LLC
Application: NDA021855
Marketing category: NDA
Marketing start: 2018-12-15
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70677-0060		D	Discontinued by firm		2026-10-15
excluded package	package	70677-0060	70677-0060-1	D	Discontinued by firm		2026-10-15

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 product	product	70677-0060		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70677-0060	70677-0060-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`c2088c7a36db…`
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…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-0060-1	EA - Each	70677-0060	e31851b5-01dd-476c-a416-7a92b216eca1	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-0060	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES, LLC]	4	Legacy NDC	20240111_01434d38-2c9d-4222-adb8-cf7b4909cac8.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
70677-0060-1	70677006001	2 BLISTER PACK in 1 CARTON (70677-0060-1) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2018-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	STRATEGIC SOURCING SERVICES, LLC \| Bionpharma Inc. \| Patheon Softgels Inc.	2024-01-10	HUMAN OTC DRUG LABEL	4