Esomeprazole magnesium

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: Esomeprazole magnesium
Generic name: ESOMEPRAZOLE MAGNESIUM
Manufacturer: BETTER LIVING BRANDS, LLC
Product type: HUMAN OTC DRUG
SPL set ID: eb4c1cac-89a2-c040-e053-2995a90ae1cd
SPL ID: 0a55d8b3-0539-2e0d-e063-6294a90a92a4
Version: 4
Effective date: 2023-11-17
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:25:12

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	217264	derived:openfda.application_number
application number		ANDA217264	openfda.application_number
brand name		Esomeprazole magnesium	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		BETTER LIVING BRANDS, LLC	openfda.manufacturer_name
ndc	package	21130-718-45	openfda.package_ndc
ndc	package	21130-718-41	openfda.package_ndc
ndc	package	21130-718-82	openfda.package_ndc
ndc	product	21130-718	openfda.product_ndc
ndc11	package	21130071882	derived:openfda.package_ndc
ndc11	package	21130071845	derived:openfda.package_ndc
ndc11	package	21130071841	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		0a55d8b3-0539-2e0d-e063-6294a90a92a4	id
spl set id		eb4c1cac-89a2-c040-e053-2995a90ae1cd	set_id
unii		R6DXU4WAY9	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 esomeprazole Esomeprazole may cause severe skin reactions. Symptoms include: -skin reddening -blisters -rash If an allergic reaction occurs, stop use and seek medical attention right away.

Reported adverse events (FAERS/openFDA)#

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