FDA.reportPublic FDA data

Omeprazole

Manufacturer
BI-MART | Sun Pharmaceutical Industries Limited
Effective date
2025-04-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:58:40

Label at a glance#

ProductOmeprazole
Active ingredientOMEPRAZOLE
Label structure11 sections

Dosage and administration

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 di...

Storage and handling

read the directions and warnings before use keep the carton. It contains important information. store at 20 to 25° C (68 to 77° F) and protect from moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole USP 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

  • treats frequent heartburn (occurs 2 or moredays a week)
  • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

  • 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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

STORAGE AND HANDLING SECTION

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20 to 25° C (68 to 77° F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide.

The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-912-4012 weekdays.

SPL UNCLASSIFIED SECTION

Distributed by:
BI-MART
Eugene, OR 97402

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Prilosec OTC ®

NDC 37835-001-42

BI-MART

Treats FREQUENT Heartburn!

24
HR

Omeprazole
Delayed-Release Tablets 20 mg / Acid Reducer

SWALLOW- DO NOT CHEW

42 Tablets

THREE 14-DAY COURSES OF TREATMENT

May take 1 to 4 days for full effect

bimart carton 42 countbimart carton 42 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN4
402014omeprazole 20 MG Delayed Release Oral TabletSCD4
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-001-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE14
37835-001-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE144
37835-001-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE34
37835-001-42Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-001OMEPRAZOLE TABLET, DELAYED RELEASE [BI-MART]4Current NDC, Legacy NDC, 4 package rows20250406_fb089d15-daa4-477a-be83-ecd55c3283d4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37835-00137835-001-42, 37835-001-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS LACTOSE3SY5LH9PMKIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)36BGF0E889IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MONOETHANOLAMINE5KV86114PTIACT
METHYLCELLULOSE (1500 MPA.S)P0NTE48364IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SODIUM STEARATEQU7E2XA9TGIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
AMMONIA5138Q19F1XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
SHELLAC46N107B71OIACT
OMEPRAZOLEKG60484QX9ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207891-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-1284e616aacf4f…
2026-08-18 06:07:402026-07A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-123f01610625f2…
2019-09-15 20:21 UTC2019-09A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207891-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-10-12f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEBI-MARTfb089d15-daa4-477a-be83-ecd55c3283d42025-04-03WarningsExact identifier
ndc (package): 37835-001-42
ndc (package): 37835-001-14
ndc (product): 37835-001
ndc11 (package): 37835000114
ndc11 (package): 37835000142
spl id: 31dbc48a-ec90-e368-e063-6294a90a6c96
spl set id: fb089d15-daa4-477a-be83-ecd55c3283d4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.