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.
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
- Brand name
- Omeprazole
- Generic name
- OMEPRAZOLE
- Manufacturer
- P & L Development, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 44a92926-1941-4fe8-9b2a-31a45289456f
- SPL ID
- 1ef5cd55-c1c3-40a9-9486-91ad26c24a1c
- Version
- 4
- Effective date
- 2025-06-02
- Source export date
- 2026-11-06
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:34:27
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 206582 | derived:openfda.application_number |
| application number | ANDA206582 | openfda.application_number | |
| brand name | Omeprazole | openfda.brand_name | |
| generic name | OMEPRAZOLE | openfda.generic_name | |
| manufacturer name | P & L Development, LLC | openfda.manufacturer_name | |
| ndc | package | 59726-298-14 | openfda.package_ndc |
| ndc | product | 59726-298 | openfda.product_ndc |
| ndc11 | package | 59726029814 | derived:openfda.package_ndc |
| rxcui | 402014 | openfda.rxcui | |
| spl id | 1ef5cd55-c1c3-40a9-9486-91ad26c24a1c | id | |
| spl set id | 44a92926-1941-4fe8-9b2a-31a45289456f | set_id | |
| unii | 426QFE7XLK | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.