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
- PLD Acquisitions LLC DBA Avma Pharma Solutions
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e67bf2c6-0618-48e0-aa08-705501d86431
- SPL ID
- 4e880f49-93d0-436b-a072-c3286d358e45
- Version
- 3
- Effective date
- 2026-06-26
- Source export date
- 2026-10-30
- 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/2026-10-30/9dea423b9e87a781c152bc6e136923fb91acb0732a7a0ec0d2a51142148f160c/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:43:42
| 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 | PLD Acquisitions LLC DBA Avma Pharma Solutions | openfda.manufacturer_name | |
| ndc | package | 63548-8040-2 | openfda.package_ndc |
| ndc | package | 63548-8040-4 | openfda.package_ndc |
| ndc | package | 63548-8040-8 | openfda.package_ndc |
| ndc | product | 63548-8040 | openfda.product_ndc |
| ndc11 | package | 63548804008 | derived:openfda.package_ndc |
| ndc11 | package | 63548804004 | derived:openfda.package_ndc |
| ndc11 | package | 63548804002 | derived:openfda.package_ndc |
| rxcui | 402014 | openfda.rxcui | |
| spl id | 4e880f49-93d0-436b-a072-c3286d358e45 | id | |
| spl set id | e67bf2c6-0618-48e0-aa08-705501d86431 | 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.