Anti-Diarrheal

Product NDC: 70000-0230
11-digit product format: 700000230
Labeler code: 70000
Product ID: 70000-0230_7573be11-02ad-4cc8-b2ad-f0f67ad600bd
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Cardinal Health (Leader) 70000
Application: NDA021855
Marketing category: NDA
Marketing start: 2017-01-31
Marketing end: 2023-12-31
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
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	70000-0230		D	Discontinued by firm		2026-08-07
excluded package	package	70000-0230	70000-0230-1	D	Discontinued by firm		2026-08-07

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 · 24 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	70000-0230-1	`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	70000-0230-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70000-0230-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70000-0230-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70000-0230-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70000-0230-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70000-0230-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70000-0230-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70000-0230-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70000-0230-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70000-0230-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70000-0230-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0230-1	EA - Each	70000-0230	a58e6b35-f589-4be8-a319-e2c24977f7da	1	2017-11-06

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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	04a35525-ae8e-b41e-e063-6294a90ab10e	2026-04-20	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CVS Pharmacy, Inc.	60bc8f05-f35e-45e0-ba3b-c82a87d60f5b	2026-02-27	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	31bfcbb4-c58c-4edc-ac68-356a448b7507	2025-12-22	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	WALGREENS	50814751-8bee-4768-bf6c-e9da3400090b	2025-12-15	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	TARGET Corporation	ee8a6bdf-847e-4b88-8aea-6d3daa669994	2025-12-12	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	440fb3ce-4106-4169-b187-cfbfdd2f42c1	2025-12-11	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35a938af-decf-5b5d-e063-6294a90a9ab0	2025-05-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35aa2daf-3486-7ee2-e063-6394a90ad473	2025-05-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Albertsons Companies	1d4ec76d-ff0d-a55d-e063-6294a90ae22c	2025-04-07	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DISCOUNT DRUG MART, INC.	ed28814d-9733-46ff-930f-b148e31f2f51	2024-12-23	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	KROGER COMPANY	ff5dcb48-318c-4f2a-8df2-73ff6dd2a49e	2024-12-23	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	17035ff7-8ba8-131c-e063-6394a90af5ea	2024-10-03	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CARDINAL HEALTH	bd58d6e9-628c-4c6b-b44c-da95e0417ba7	2024-05-31	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	a14bd404-cc79-06e0-e053-2a95a90a6841	2023-12-26	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	fed347ad-cfbb-9ee8-e053-6394a90ad275	2023-10-10	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES	f9e03d2b-2ec0-322b-e053-6394a90a1599	2023-04-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	TOP CARE (Topco Associates LLC)	c62bc8d4-0857-16fc-e053-2a95a90a0c41	2022-12-30	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
ANTI-DIARRHEAL	LOPERAMIDE HYDROCHLORIDE	Northeast Pharma	c2db4155-68d4-71be-e053-2a95a90a7f35	2022-12-30	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Premier Value Alliance LLC	0dd97bfb-67ce-472f-9b23-15f613bb3135	2022-12-29	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Wal-Mart Stores, Inc.	507acd63-b2b4-465e-bb94-2d66724de20a	2022-12-29	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
70000-0230-1	70000023001	2 BLISTER PACK in 1 CARTON (70000-0230-1) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2017-01-31	2023-12-31	No	No	Current