Loperamide Hydrochloride, Simethicone

Product NDC: 53041-263
11-digit product format: 530410263
Labeler code: 53041
Product ID: 53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide Hydrochloride, Simethicone
Dosage form: TABLET
Route: ORAL
Labeler: Guardian Drug Company
Application: ANDA214541
Marketing category: ANDA
Marketing start: 2021-06-01
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 42.

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
A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET / ORAL			2021-05-27

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
2026-08-18 06:07:40	2026-07	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214541-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-05-27	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loperamide Hydrochloride, Simethicone
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
1b79204e-8a99-455b-84d6-f381fd7d1135	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
53041-263-50	Loperamide Hydrochloride, Simethicone	1 in 1 CARTON	TABLET	1		2
53041-263-50	Loperamide Hydrochloride, Simethicone	6 in 1 BLISTER PACK	TABLET	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53041-263	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE TABLET [GUARDIAN DRUG COMPANY]	2	Current NDC, Legacy NDC, 2 package rows	20210602_1b79204e-8a99-455b-84d6-f381fd7d1135.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal/Anti-Gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Discount Drug Mart, Inc	2e0b3aec-f436-c0fb-e063-6394a90abb51	2025-02-27	Warnings	Exact identifier application applno (ANDA): 214541 application number: ANDA214541
Anti-Diarrheal/Anti-Gas	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Harris Teeter, LLC	2c4f882b-89d5-42ce-e063-6294a90a5fbe	2025-02-05	Warnings	Exact identifier application applno (ANDA): 214541 application number: ANDA214541
Anti-Diarrheal/Anti-Gas Multi-Symptom Relief	LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG	Wal-Mart Stores, Inc.	a4d5dd69-22cf-4d00-b539-133886c09e37	2025-01-09	Warnings	Exact identifier application applno (ANDA): 214541 application number: ANDA214541
Equate Anti Diarrheal Anti Gas Multi-Symptom Relief	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	WALMART INC.	23af573f-8d40-6b82-e063-6394a90aabab	2025-01-01	Warnings	Exact identifier application applno (ANDA): 214541 application number: ANDA214541
Loperamide Hydrochloride, Simethicone	LOPERAMIDE HYDROCHLORIDE, SIMETHICONE	Guardian Drug Company	1b79204e-8a99-455b-84d6-f381fd7d1135	2021-06-01	Warnings	Exact identifier application applno (ANDA): 214541 application number: ANDA214541 ndc (product): 53041-263

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	1b79204e-8a99-455b-84d6-f381fd7d1135	2
978001	loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet	SCD	1b79204e-8a99-455b-84d6-f381fd7d1135	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53041-263-50	53041026350	1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK	1 blister pack	2021-06-01	0000-00-00	No	No	Current