Imodium Multi-Symptom Relief

NDA 21140, held by Kenvue Brands. Loperamide Hydrochloride; Simethicone.

As of Nov 14, 2026, NDA 21140 (Imodium Multi-Symptom Relief), held by Kenvue Brands, was first approved by FDA on Nov 30, 2000, with 16 approved supplements and 0 published complete response letters.

First approved: Nov 30, 2000
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Apr 30, 2008	Supplement 11Efficacy (new indication or use)	Approved	Summary Review Letter
Nov 30, 2000	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imodium Multi-Symptom Relief2MG;125MG · tablet;oral	Loperamide Hydrochloride; Simethicone	OTCReference drug

All 17 submissions, including labeling and manufacturing supplements


Mar 2, 2026	Supplement 39Manufacturing	Approved	Letter Label
Dec 11, 2018	Supplement 26Labeling · Standard review	Approved	Letter Label
Apr 12, 2017	Supplement 25Labeling · Standard review	Approved	Letter Label
Dec 2, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 1, 2015	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 7, 2015	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 3, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 18, 2015	Supplement 20Labeling · Standard review	Approved	Label Letter
Feb 3, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
May 3, 2012	Supplement 16Labeling · Standard review	Approved	Letter
Apr 30, 2008	Supplement 11Efficacy (new indication or use)	Approved	Summary Review Letter
Feb 5, 2008	Supplement 13Labeling · Standard review	Approved	Letter
Sep 14, 2007	Supplement 12Manufacturing	Approved	Letter Label
Jun 16, 2004	Supplement 3Labeling · Standard review	Approved	Review Letter
Jan 27, 2003	Supplement 2Labeling · Standard review	Approved	Letter Label
Sep 12, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 30, 2000	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 21140
Drugs@FDA: Overview at FDA
Company: Kenvue Brands

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters