Zegerid Otc

NDA 22281, held by Riley Consumer. Omeprazole; Sodium Bicarbonate.

As of Nov 15, 2026, NDA 22281 (Zegerid Otc), held by Riley Consumer, was first approved by FDA on Dec 1, 2009, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 1, 2009
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Dec 1, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zegerid Otc20MG;1.1GM · capsule;oral	Omeprazole; Sodium Bicarbonate	OTCReference drug

All 16 submissions, including labeling and manufacturing supplements


Nov 25, 2025	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 24, 2023	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 13, 2022	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 1, 2022	Supplement 14Labeling · Standard review	Approved	Label Letter
Jan 15, 2019	Supplement 13Labeling · Standard review	Approved	Label Letter
Oct 30, 2017	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 17, 2017	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 21, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 10, 2015	Supplement 8Labeling · Standard review	Approved	Label Letter
Nov 15, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 18, 2012	Supplement 6Labeling · Standard review	Approved	Label Letter
Jul 25, 2011	Supplement 5Labeling · Standard review	Approved	Label Letter
Dec 20, 2010	Supplement 2Labeling · Standard review	Approved	Letter
Dec 20, 2010	Supplement 3Labeling · Standard review	Approved	Letter
Apr 15, 2010	Supplement 1Labeling · Standard review	Approved	Letter
Dec 1, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 22281
Drugs@FDA: Overview at FDA
Company: Riley Consumer

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