anti diarrheal and anti gas

Product NDC: 69842-644
11-digit product format: 698420644
Labeler code: 69842
Product ID: 69842-644_927820f7-afd0-4433-9202-86729b523a61
Type: HUMAN OTC DRUG
Nonproprietary name: loperamide hydrochloride, simethicone
Dosage form: TABLET
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA209837
Marketing category: ANDA
Marketing start: 2019-08-06
Substance: DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength: 125; 2 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: anti diarrheal and anti gas
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	125 mg/1
DIMETHICONE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
77TI35393C	Internal UNII lookup
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978001	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
065699b5-217e-432f-a253-cea2d3f62233	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
69842-644-53	anti diarrheal and anti gas	12 in 1 CARTON	TABLET	12	4
69842-644-53	anti diarrheal and anti gas	1 in 1 BLISTER PACK	TABLET	1	4
69842-644-62	anti diarrheal and anti gas	1 in 1 BLISTER PACK	TABLET	1	4
69842-644-62	anti diarrheal and anti gas	24 in 1 CARTON	TABLET	24	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-644	ANTI DIARRHEAL AND ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [CVS PHARMACY]	4	Current NDC, Legacy NDC, 4 package rows	20240724_065699b5-217e-432f-a253-cea2d3f62233.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 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 ndc (product): 69842-644
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
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978001	loperamide HCl 2 MG / simethicone 125 MG Oral Tablet	PSN	065699b5-217e-432f-a253-cea2d3f62233	4
978001	loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet	SCD	065699b5-217e-432f-a253-cea2d3f62233	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-644-53	69842064453	12 BLISTER PACK in 1 CARTON (69842-644-53) / 1 TABLET in 1 BLISTER PACK	12 blister pack	2022-10-25	0000-00-00	No	No	Current
69842-644-62	69842064462	24 BLISTER PACK in 1 CARTON (69842-644-62) / 1 TABLET in 1 BLISTER PACK	24 blister pack	2019-08-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Anti-Diarrheal & Anti-Gas Drug Facts	CVS Pharmacy	2024-07-20	HUMAN OTC DRUG LABEL	4