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Acid Reducer

Omeprazole · Tablet, Delayed Release

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Acid Reducer
Generic name
Omeprazole
Dosage form
Tablet, Delayed Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
20
Packages
49
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Esomeprazole Magnesium 20 mg/1 606726 View
Omeprazole Magnesium 20 mg/1 198051 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Delayed Release
Route of administration
Oral
Presentations
69

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 2C19 Inhibitors [MoA] MoA All 93 members
Proton Pump Inhibitor [EPC] EPC All 74 members
Proton Pump Inhibitors [MoA] MoA All 74 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
206877
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 6, 2018
Sponsor
AUROBINDO PHARMA
Products on application
1
Submissions recorded
5
Products approved under application 206877.
Product Trade name Form Strength Ingredient Status TE Flags
206877-001 OMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE OMEPRAZOLE MAGNESIUM Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 206877.
Type No. Action Status Date Review
Supplement 12 Labeling Approved November 8, 2024 Standard
Supplement 8 Labeling Approved November 8, 2024 Standard
Supplement 5 Labeling Approved November 8, 2024 Standard
Supplement 3 Labeling Approved November 8, 2024 Standard
Original application 1 Approved June 6, 2018 Standard

Review documents

  • 0 · Original application · January 8, 2018

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260604). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260604 HUMAN OTC DRUG · 20260121 HUMAN OTC DRUG · 20240615 HUMAN OTC DRUG · 20231202

Indications and Usage

openFDA Drug Labeling

Uses 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

Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets. Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Warnings Allergy alert: • Do not use if you are allergic to omeprazole. • Omeprazole may cause severe skin reactions. Symptoms may Include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right way.

Do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain. These may be signs of a serious condition. See your doctor.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have: had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain

Stop use and ask a doctor if : your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP trihydrate)

Adverse event reports

Source: openFDA FAERS
444,608
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OMEPRAZOLE MAGNESIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
10202-722-05 10202-722 7-Eleven 1 BOTTLE in 1 CARTON (10202-722-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
58602-729-01 58602-729 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-729-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK June 6, 2018
58602-729-02 58602-729 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-729-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK June 6, 2018
58602-729-03 58602-729 Aurohealth LLC 3 BLISTER PACK in 1 CARTON (58602-729-03) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK June 6, 2018
58602-729-05 58602-729 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-729-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
58602-729-61 58602-729 Aurohealth LLC 2 BOTTLE in 1 CARTON (58602-729-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
58602-729-62 58602-729 Aurohealth LLC 3 BOTTLE in 1 CARTON (58602-729-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
58602-729-65 58602-729 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-729-65) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (58602-729-64) June 6, 2018
58602-826-05 58602-826 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-826-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
58602-826-61 58602-826 Aurohealth LLC 2 BOTTLE in 1 CARTON (58602-826-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
58602-826-62 58602-826 Aurohealth LLC 3 BOTTLE in 1 CARTON (58602-826-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
58602-850-05 58602-850 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-850-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE May 16, 2020
58602-850-62 58602-850 Aurohealth LLC 3 BOTTLE in 1 CARTON (58602-850-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE May 16, 2020
63941-006-05 63941-006 Best Choice 1 BOTTLE in 1 CARTON (63941-006-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
63941-006-62 63941-006 Best Choice 3 BOTTLE in 1 CARTON (63941-006-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
37835-189-14 37835-189 Bi-Mart 1 BOTTLE in 1 CARTON (37835-189-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
37835-189-42 37835-189 Bi-Mart 3 BOTTLE in 1 CARTON (37835-189-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
69842-679-14 69842-679 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 CARTON (69842-679-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC December 31, 2021
69842-679-42 69842-679 CVS Pharmacy 3 BOTTLE, PLASTIC in 1 CARTON (69842-679-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC December 31, 2021
69842-941-01 69842-941 CVS Pharmacy, Inc. 1 BLISTER PACK in 1 CARTON (69842-941-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK September 23, 2020
69842-941-03 69842-941 CVS Pharmacy, Inc. 3 BLISTER PACK in 1 CARTON (69842-941-03) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK September 23, 2020
69842-941-05 69842-941 CVS Pharmacy, Inc. 1 BOTTLE in 1 CARTON (69842-941-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 23, 2020
69842-941-61 69842-941 CVS Pharmacy, Inc. 2 BOTTLE in 1 CARTON (69842-941-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 23, 2020
69842-941-62 69842-941 CVS Pharmacy, Inc. 3 BOTTLE in 1 CARTON (69842-941-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 23, 2020
70000-0521-1 70000-0521 Cardinal Health 1 BOTTLE in 1 CARTON (70000-0521-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
70000-0521-2 70000-0521 Cardinal Health 1 BLISTER PACK in 1 CARTON (70000-0521-2) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 21, 2020
70000-0521-3 70000-0521 Cardinal Health 2 BOTTLE in 1 CARTON (70000-0521-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE October 21, 2020
70000-0521-4 70000-0521 Cardinal Health 3 BOTTLE in 1 CARTON (70000-0521-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE October 21, 2020
53943-016-05 53943-016 DISCOUNT DRUG MART 1 BOTTLE in 1 CARTON (53943-016-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
53943-016-62 53943-016 DISCOUNT DRUG MART 3 BOTTLE in 1 CARTON (53943-016-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
55319-037-05 55319-037 Family Dollar Stores, LLC 1 BOTTLE in 1 CARTON (55319-037-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 17, 2024
55319-037-62 55319-037 Family Dollar Stores, LLC 3 BOTTLE in 1 CARTON (55319-037-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 17, 2024
55315-996-04 55315-996 Fred's, Inc. 3 BOTTLE in 1 CARTON (55315-996-04) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
55315-996-74 55315-996 Fred's, Inc. 1 BOTTLE in 1 CARTON (55315-996-74) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
57483-120-14 57483-120 INNOVUS PHARMACEUTICALS, INC. 1 BOTTLE in 1 CARTON (57483-120-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 4, 2026
57483-120-42 57483-120 INNOVUS PHARMACEUTICALS, INC. 3 BOTTLE in 1 CARTON (57483-120-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE May 25, 2023
30142-077-01 30142-077 KROGER COMPANY 1 BLISTER PACK in 1 CARTON (30142-077-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 13, 2023
30142-077-05 30142-077 KROGER COMPANY 1 BOTTLE in 1 CARTON (30142-077-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 13, 2023
80136-852-03 80136-852 NORTHEAST PHARMA 3 BOTTLE in 1 CARTON (80136-852-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE July 5, 2021
80136-852-42 80136-852 NORTHEAST PHARMA 3 BLISTER PACK in 1 CARTON (80136-852-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK January 13, 2022
69618-054-42 69618-054 RELIABLE 1 LABORATORIES LLC 3 BOTTLE in 1 CARTON (69618-054-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 11, 2021
0536-1322-13 0536-1322 Rugby Laboratories 3 BOTTLE in 1 CARTON (0536-1322-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 15, 2020
0536-1322-71 0536-1322 Rugby Laboratories 2 BOTTLE in 1 CARTON (0536-1322-71) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 15, 2020
0536-1322-88 0536-1322 Rugby Laboratories 1 BOTTLE in 1 CARTON (0536-1322-88) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 15, 2020
0363-1008-05 0363-1008 WALGREEN CO. 1 BOTTLE in 1 CARTON (0363-1008-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE May 6, 2021
0363-1008-61 0363-1008 WALGREEN CO. 2 BOTTLE in 1 CARTON (0363-1008-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE May 6, 2021
0363-1008-62 0363-1008 WALGREEN CO. 3 BOTTLE in 1 CARTON (0363-1008-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE May 6, 2021
49035-983-62 49035-983 Wal-Mart Stores, Inc. 3 BOTTLE in 1 CARTON (49035-983-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49035-983-05) June 6, 2018
67091-316-14 67091-316 Winco Foods, LLC. 1 BOTTLE in 1 CARTON (67091-316-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 6, 2018
10202-722 10202-722 7-Eleven — June 6, 2018
58602-729 58602-729 Aurohealth LLC — June 6, 2018
58602-826 58602-826 Aurohealth LLC — June 6, 2018
58602-850 58602-850 Aurohealth LLC — May 16, 2020
63941-006 63941-006 Best Choice — June 6, 2018
37835-189 37835-189 Bi-Mart — June 6, 2018
69842-679 69842-679 CVS Pharmacy — December 31, 2021
69842-941 69842-941 CVS Pharmacy, Inc. — September 23, 2020
70000-0521 70000-0521 Cardinal Health — June 6, 2018
53943-016 53943-016 DISCOUNT DRUG MART — June 6, 2018
55319-037 55319-037 Family Dollar Stores, LLC — June 17, 2024
55315-996 55315-996 Fred's, Inc. — June 6, 2018
57483-120 57483-120 INNOVUS PHARMACEUTICALS, INC. — May 25, 2023
30142-077 30142-077 KROGER COMPANY — March 13, 2023
80136-852 80136-852 NORTHEAST PHARMA — July 5, 2021
69618-054 69618-054 RELIABLE 1 LABORATORIES LLC — March 11, 2021
0536-1322 0536-1322 Rugby Laboratories — September 15, 2020
0363-1008 0363-1008 WALGREEN CO. — May 6, 2021
49035-983 49035-983 Wal-Mart Stores, Inc. — June 6, 2018
67091-316 67091-316 Winco Foods, LLC. — June 6, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.