Loperamide Hydrochloride and Simethicone

Product NDC: 84441-713
Requested package NDC: 84441-713-10
11-digit product format: 844410713
Labeler code: 84441
Product ID: 84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8fa
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide Hydrochloride and Simethicone
Dosage form: TABLET
Route: ORAL
Labeler: IMO-GEN LABS LLC
Application: ANDA211438
Marketing category: ANDA
Marketing start: 2025-10-23
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 43.

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
A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET / ORAL			2021-06-17

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Loperamide Hydrochloride and Simethicone
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup
77TI35393C	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
41d6dba5-e411-c8d2-e063-6294a90ae8fa	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	Strength	SPL version
84441-713-10	Loperamide Hydrochloride and Simethicone	100 in 1 BOTTLE	TABLET	100		1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride and Simethicone	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	IMO-GEN LABS LLC	41d6dba5-e411-c8d2-e063-6294a90ae8fa	2025-10-23	Warnings	Exact identifier application applno (ANDA): 211438 application number: ANDA211438 ndc (package): 84441-713-10 ndc (product): 84441-713 ndc11 (package): 84441071310
Loperamide Hydrochloride and Simethicone	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	FSA store INC	0199a50f-f367-40e7-8af0-745a959d3fde	2025-04-05	Warnings	Exact identifier application applno (ANDA): 211438 application number: ANDA211438
Loperamide Hydrochloride and Simethicone	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	Camber Consumer Care Inc	e2a4af66-1d05-408c-9f11-f2a9f325d75c	2022-09-12	Warnings	Exact identifier application applno (ANDA): 211438 application number: ANDA211438

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	41d6dba5-e411-c8d2-e063-6294a90ae8fa	1
978001	loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet	SCD	41d6dba5-e411-c8d2-e063-6294a90ae8fa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84441-713-10	84441071310	100 TABLET in 1 BOTTLE (84441-713-10)	100 tablet	2025-10-23	No	No	Current