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Signature Care Omeprazole

Omeprazole · Tablet, Delayed Release

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
Signature Care Omeprazole
Generic name
Omeprazole
Dosage form
Tablet, Delayed Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Safeway
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
4
Data completeness
76% 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, Delayed Release
Route of administration
Oral
Presentations
6

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
022032
Application type
NDA · New Drug Application
Approval date
December 4, 2007
Sponsor
DEXCEL PHARMA
Products on application
1
Submissions recorded
27
Products approved under application 022032.
Product Trade name Form Strength Ingredient Status TE Flags
022032-001 OMEPRAZOLE TABLET, 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
12599565 January 31, 2030 001 No May 11, 2026

Approval history

Source: Drugs@FDA
Most recent submissions on application 022032.
Type No. Action Status Date Review
Supplement 70 Manufacturing (CMC) Approved October 3, 2025 N/A
Supplement 65 Manufacturing (CMC) Approved November 8, 2024 N/A
Supplement 57 Labeling Approved September 30, 2022 Standard
Supplement 52 Manufacturing (CMC) Approved October 21, 2021 N/A
Supplement 46 Labeling Approved July 7, 2021 Standard
Supplement 41 Labeling Approved April 8, 2019 Standard
Supplement 38 Labeling Approved November 13, 2017 Standard
Supplement 37 Labeling Approved October 30, 2017 Standard
Supplement 34 Manufacturing (CMC) Approved December 1, 2016 Standard
Supplement 32 Labeling Approved February 10, 2016 Standard
Supplement 31 Manufacturing (CMC) Approved February 8, 2016 Standard
Supplement 25 Manufacturing (CMC) Approved January 5, 2016 Standard
Supplement 26 Manufacturing (CMC) Approved August 7, 2015 Standard
Supplement 29 Labeling Approved June 11, 2015 Standard
Supplement 28 Manufacturing (CMC) Approved June 1, 2015 Standard
Supplement 27 Manufacturing (CMC) Approved March 30, 2015 Standard
Supplement 24 Manufacturing (CMC) Approved March 6, 2015 Standard
Supplement 22 Manufacturing (CMC) Approved September 13, 2013 Standard
Supplement 21 Labeling Approved August 16, 2013 Standard
Supplement 20 Labeling Approved October 29, 2012 Standard
Supplement 19 Labeling Approved September 10, 2012 Standard
Supplement 16 Labeling Approved April 9, 2012 Standard
Supplement 12 Labeling Approved June 27, 2011 Unknown
Supplement 8 Labeling Approved July 16, 2010 Standard
Supplement 4 Manufacturing (CMC) Approved September 21, 2009 N/A
Supplement 3 Labeling Approved April 2, 2009 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved December 4, 2007 Standard

Review documents

  • 0 · Supplement · October 7, 2025
  • 0 · Supplement · October 6, 2025
  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · October 17, 2022
  • 0 · Supplement · October 13, 2022
  • 0 · Supplement · October 5, 2022
  • 0 · Supplement · October 3, 2022
  • 0 · Supplement · July 8, 2021
  • 0 · Supplement · April 10, 2019
  • 0 · Supplement · April 10, 2019
  • 0 · Supplement · November 15, 2017
  • 0 · Supplement · November 14, 2017
  • 0 · Supplement · November 13, 2017
  • 0 · Supplement · November 6, 2017
  • 0 · Supplement · February 11, 2016
  • 0 · Supplement · February 11, 2016
  • 0 · Supplement · June 19, 2015
  • 0 · Supplement · June 12, 2015
  • 0 · Supplement · March 12, 2015
  • 0 · Supplement · March 10, 2015
  • 0 · Supplement · January 15, 2014
  • 0 · Supplement · September 19, 2013
  • 0 · Supplement · August 20, 2013
  • 0 · Supplement · October 30, 2012
  • 0 · Supplement · September 11, 2012
  • 0 · Supplement · April 11, 2012
  • 0 · Supplement · July 5, 2011
  • 0 · Supplement · July 23, 2010

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250414). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250414 HUMAN OTC DRUG · 20250206

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

openFDA Drug Labeling

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, crush, or suck 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

openFDA Drug Labeling

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 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 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

openFDA Drug Labeling

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

openFDA Drug Labeling

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
21130-137-55 21130-137 Safeway 3 CARTON in 1 CARTON (21130-137-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 11, 2015
21130-137-74 21130-137 Safeway 14 BLISTER PACK in 1 CARTON (21130-137-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK September 18, 2015
21130-401-01 21130-401 Safeway 1 BOTTLE in 1 CARTON (21130-401-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 11, 2020
21130-401-03 21130-401 Safeway 3 BOTTLE in 1 CARTON (21130-401-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 14, 2020
21130-137 21130-137 Safeway — September 18, 2015
21130-401 21130-401 Safeway — August 11, 2020

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 · 12 sections on this page.