Prilosec OTC

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Prilosec OTC
Generic name: OMEPRAZOLE MAGNESIUM
Manufacturer: The Procter & Gamble Manufacturing Company
Product type: HUMAN OTC DRUG
SPL set ID: 77ed80a2-a482-4838-ac55-4865b5c31d9f
SPL ID: 401e1256-05e3-d4a9-e063-6294a90adce4
Version: 16
Effective date: 2025-10-01
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:30

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 21 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	021229	derived:openfda.application_number
application number		NDA021229	openfda.application_number
brand name		Prilosec OTC	openfda.brand_name
generic name		OMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		The Procter & Gamble Manufacturing Company	openfda.manufacturer_name
ndc	package	37000-455-01	openfda.package_ndc
ndc	package	37000-455-03	openfda.package_ndc
ndc	package	37000-455-02	openfda.package_ndc
ndc	package	37000-455-05	openfda.package_ndc
ndc	package	37000-455-04	openfda.package_ndc
ndc	product	37000-455	openfda.product_ndc
ndc11	package	37000045502	derived:openfda.package_ndc
ndc11	package	37000045505	derived:openfda.package_ndc
ndc11	package	37000045504	derived:openfda.package_ndc
ndc11	package	37000045501	derived:openfda.package_ndc
ndc11	package	37000045503	derived:openfda.package_ndc
rxcui		402014	openfda.rxcui
rxcui		608796	openfda.rxcui
spl id		401e1256-05e3-d4a9-e063-6294a90adce4	id
spl set id		77ed80a2-a482-4838-ac55-4865b5c31d9f	set_id
unii		426QFE7XLK	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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.

Reported adverse events (FAERS/openFDA)#

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