Omeprazole

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: Omeprazole
Generic name: OMEPRAZOLE
Manufacturer: CHAIN DRUG MARKETING ASSOCIATION, INC.
Product type: HUMAN OTC DRUG
SPL set ID: da09aac6-8fce-448b-98ba-1fc9bce42075
SPL ID: 164b1d0f-ad03-40dd-e063-6394a90a6771
Version: 2
Effective date: 2024-04-17
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:17:48

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	211732	derived:openfda.application_number
application number		ANDA211732	openfda.application_number
brand name		Omeprazole	openfda.brand_name
generic name		OMEPRAZOLE	openfda.generic_name
manufacturer name		CHAIN DRUG MARKETING ASSOCIATION, INC.	openfda.manufacturer_name
ndc	package	83324-011-14	openfda.package_ndc
ndc	package	83324-011-42	openfda.package_ndc
ndc	product	83324-011	openfda.product_ndc
ndc11	package	83324001114	derived:openfda.package_ndc
ndc11	package	83324001142	derived:openfda.package_ndc
rxcui		402014	openfda.rxcui
spl id		164b1d0f-ad03-40dd-e063-6394a90a6771	id
spl set id		da09aac6-8fce-448b-98ba-1fc9bce42075	set_id
unii		KG60484QX9	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 allergy 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.