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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021140

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NDA 021140 describes IMODIUM MULTI-SYMPTOM RELIEF, which is a drug marketed by J And J Consumer Inc and Kenvue Brands and is included in two NDAs. It is available from one supplier. Additional details are available on the IMODIUM MULTI-SYMPTOM RELIEF profile page.

The generic ingredient in IMODIUM MULTI-SYMPTOM RELIEF is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

Summary for 021140

Tradename:	IMODIUM MULTI-SYMPTOM RELIEF
Applicant:	Kenvue Brands
Ingredient:	loperamide hydrochloride; simethicone
Patents:	0

Pharmacology for NDA: 021140

Mechanism of Action	Opioid Agonists
Physiological Effect	Skin Barrier Activity

Suppliers and Packaging for NDA: 021140

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140	NDA	Kenvue Brands LLC	50580-338	50580-338-06	1 BLISTER PACK in 1 CARTON (50580-338-06) / 6 TABLET in 1 BLISTER PACK
IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140	NDA	Kenvue Brands LLC	50580-338	50580-338-12	2 BLISTER PACK in 1 CARTON (50580-338-12) / 6 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	2MG;125MG
Approval Date:	Nov 30, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021140

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000	5,248,505	⤷ Get Started Free
Kenvue Brands	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000	6,103,260	⤷ Get Started Free
Kenvue Brands	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000	5,612,054	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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