basic care loperamide hydrochloride and simethicone

Product NDC: 0113-7119
11-digit product format: 001137119
Labeler code: 0113
Product ID: 0113-7119_bcd8ff73-20c4-42c3-966a-13bda1260399
Type: HUMAN OTC DRUG
Nonproprietary name: loperamide hydrochloride, simethicone
Dosage form: TABLET
Route: ORAL
Labeler: L. Perrigo Company
Application: ANDA209837
Marketing category: ANDA
Marketing start: 2018-10-17
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Active strength: 2 mg/1; mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0113-7119		D	Discontinued by firm	2026-08-03
excluded package	package	0113-7119	0113-7119-55	D	Discontinued by firm	2026-08-03
excluded package	package	0113-7119	0113-7119-62	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 · 36 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	0113-7119-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0113-7119-55	`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	0113-7119-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0113-7119-55	`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	0113-7119-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0113-7119-55	`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	0113-7119-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0113-7119-55	`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	0113-7119-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0113-7119-55	`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	0113-7119-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0113-7119-55	`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	0113-7119-62	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0113-7119-55	`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	0113-7119-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0113-7119-55	`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	0113-7119-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0113-7119-55	`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	0113-7119-62	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0113-7119-55	`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	0113-7119-62	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0113-7119-55	`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	0113-7119-62	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0113-7119-55	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET / ORAL			2018-09-05

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	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2018-09-05	`cb3db0bc1861…`

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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	L. Perrigo Company	2cda08a8-3f5e-430c-84a3-d29b97d647af	2026-05-20	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
CareOne Diarrhea and Gas Control	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	American Sales Company	dfa3db5a-cef6-4ed5-b9f1-a20b6d1657b3	2026-04-21	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	HyVee Inc	396ea4f5-5c3d-4cbc-acd5-09eb64c806e0	2026-03-02	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	H E B	35cff261-932e-4b2e-ab21-80969c27fa92	2025-06-27	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
good neighbor pharmacy anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Amerisource Bergen	5dae1247-3ec0-495e-b3f2-1c1555141617	2025-04-08	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
Anti Diarrheal Anti Gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Kroger Company	9c7db942-c8cb-493a-a96f-452b8dfebfc6	2024-07-23	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
signature care anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Safeway	53829e72-d22c-434d-a108-1972081a6efb	2024-07-22	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
anti diarrheal and anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Walgreen Company	0999243a-c3be-41a6-b327-962e63d8c356	2024-07-22	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
dg health anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Dolgencorp, LLC	09798231-39cd-49b2-9be5-ea51e52f0a6d	2024-07-22	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
Basic Care Loperamide Hydrochloride and Simethicone	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Amazon.com Services LLC	aa79234e-1fbd-4279-b4b1-46b4f041b4e8	2024-07-22	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
equaline anti diarrheal plus anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	United Natural Foods, Inc. dba UNFI	2ce0b37e-6dc4-423f-a1d6-a2cb623946d5	2024-07-22	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
up and up anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Target Corporation	ef75085c-95df-4901-9c97-069fcfc3eef7	2024-07-22	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Rite Aid Corporation	8e954f86-bc15-45e2-9274-ca5d8a7c9687	2024-07-22	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
anti diarrheal and anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	CVS Pharmacy	065699b5-217e-432f-a253-cea2d3f62233	2024-07-20	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
Good Sense Anti Diarrheal Anti Gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	L. Perrigo Company	fcfd0b64-6876-4e6f-8a7b-ca1da9e03f00	2024-07-13	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
anti diarrheal plus anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Meijer Distribution Inc	e2c9a752-618a-4e34-89a5-671aab4013ac	2024-07-11	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837
foster and thrive anti diarrheal anti gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Strategic Sourcing Services LLC	9132dc1c-8e16-4236-881e-863f5e57f0ab	2024-07-08	Warnings	Exact identifier application applno (ANDA): 209837 application number: ANDA209837

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0113-7119-55	00113711955	1 BOTTLE in 1 CARTON (0113-7119-55) > 42 TABLET in 1 BOTTLE	1 bottle	2018-10-17	0000-00-00	No	No	Current
0113-7119-62	00113711962	24 BLISTER PACK in 1 CARTON (0113-7119-62) > 1 TABLET in 1 BLISTER PACK	24 blister pack	2019-06-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amazon Loperamide Hydrochloride and Simethicone Drug Facts	L. Perrigo Company	2019-06-27	HUMAN OTC DRUG LABEL	2