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omeprazole

Over-the-counter NDA RLD 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
omeprazole
Generic name
omeprazole
Dosage form
Tablet, Orally Disintegrating, Delayed Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Meijer Distribution Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
7
Packages
10
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
Omeprazole 20 mg/1 200329 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Orally Disintegrating, Delayed Release
Route of administration
Oral
Presentations
17

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
209400
Application type
NDA · New Drug Application
Approval date
July 5, 2017
Sponsor
DEXCEL
Products on application
1
Submissions recorded
10
Products approved under application 209400.
Product Trade name Form Strength Ingredient Status TE Flags
209400-001 OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE OMEPRAZOLE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10835488 December 8, 2036 001 No November 23, 2020
10076494 December 8, 2036 001 No September 18, 2018

Approval history

Source: Drugs@FDA
Most recent submissions on application 209400.
Type No. Action Status Date Review
Supplement 21 Labeling Approved March 11, 2026 Standard
Supplement 12 Labeling Approved October 21, 2022 Standard
Supplement 6 Labeling Approved July 7, 2021 Standard
Supplement 10 Labeling Approved November 13, 2020 Standard
Supplement 7 Labeling Approved April 29, 2020 Standard
Supplement 5 Labeling Approved January 28, 2019 Standard
Supplement 3 Labeling Approved July 12, 2018 Standard
Supplement 2 Labeling Approved June 12, 2018 Standard
Supplement 1 Labeling Approved February 28, 2018 Standard
Original application 1 Type 3 - New Dosage Form Approved July 5, 2017 Standard

Review documents

  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · October 26, 2022
  • 0 · Supplement · October 24, 2022
  • 0 · Supplement · July 8, 2021
  • 0 · Supplement · November 17, 2020
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · February 13, 2019
  • 0 · Supplement · February 6, 2019
  • 0 · Supplement · August 3, 2018
  • 0 · Supplement · July 16, 2018
  • 0 · Supplement · June 21, 2018
  • 0 · Supplement · June 14, 2018
  • 0 · Original application · March 21, 2018
  • 0 · Supplement · March 15, 2018
  • 0 · Supplement · March 1, 2018
  • 0 · Original application · July 11, 2017
  • 0 · Original application · July 11, 2017

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250305). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250305 HUMAN OTC DRUG · 20250122

Indications and Usage

openFDA Drug Labeling

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

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 • take 1 tablet before eating in the morning • do not crush or chew tablets • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water. • 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 • do not take this medicine with alcohol Repeated 14-Day Course (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 before use. 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 away. 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 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 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 Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 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) Omeprazole 20 mg

Adverse event reports

Source: openFDA FAERS
448,269
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. 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
72288-666-55 72288-666 Amazon.com Services LLC 3 CARTON in 1 CARTON (72288-666-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK September 11, 2026
69842-791-55 69842-791 CVS Pharmacy 3 CARTON in 1 CARTON (69842-791-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK February 27, 2018
69842-791-74 69842-791 CVS Pharmacy 14 BLISTER PACK in 1 CARTON (69842-791-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK March 1, 2018
37808-354-55 37808-354 H E B 42 BLISTER PACK in 1 CARTON (37808-354-55) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK March 5, 2018
37808-354-74 37808-354 H E B 14 BLISTER PACK in 1 CARTON (37808-354-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK March 5, 2018
42507-164-42 42507-164 HyVee Inc 3 CARTON in 1 CARTON (42507-164-42) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK January 28, 2026
30142-394-55 30142-394 Kroger Company 3 CARTON in 1 CARTON (30142-394-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK April 10, 2018
41250-349-55 41250-349 Meijer Distribution Inc 3 CARTON in 1 CARTON (41250-349-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK March 13, 2018
0363-1819-55 0363-1819 Walgreen Company 3 CARTON in 1 CARTON (0363-1819-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK March 1, 2018
0363-1819-74 0363-1819 Walgreen Company 14 BLISTER PACK in 1 CARTON (0363-1819-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK March 6, 2018
72288-666 72288-666 Amazon.com Services LLC — September 11, 2026
69842-791 69842-791 CVS Pharmacy — February 27, 2018
37808-354 37808-354 H E B — March 5, 2018
42507-164 42507-164 HyVee Inc — January 28, 2026
30142-394 30142-394 Kroger Company — April 10, 2018
41250-349 41250-349 Meijer Distribution Inc — March 13, 2018
0363-1819 0363-1819 Walgreen Company — March 1, 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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 13 sections on this page.