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: 37291cab-e350-d8e3-e063-6294a90a9cb1
SPL ID: 57c76deb-eca8-95e0-e063-6394a90aaf9d
Version: 2
Effective date: 2026-07-29
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:18:25

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 · 19 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	206582	derived:openfda.application_number
application number		ANDA206582	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	84126-300-56	openfda.package_ndc
ndc	package	84126-300-42	openfda.package_ndc
ndc	package	84126-300-14	openfda.package_ndc
ndc	package	84126-300-24	openfda.package_ndc
ndc	product	84126-300	openfda.product_ndc
ndc11	package	84126030014	derived:openfda.package_ndc
ndc11	package	84126030024	derived:openfda.package_ndc
ndc11	package	84126030056	derived:openfda.package_ndc
ndc11	package	84126030042	derived:openfda.package_ndc
rxcui		402014	openfda.rxcui
rxcui		608796	openfda.rxcui
spl id		57c76deb-eca8-95e0-e063-6394a90aaf9d	id
spl set id		37291cab-e350-d8e3-e063-6294a90a9cb1	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.