warnings
WARNINGS
Loratadine
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
- Loratadine
- Generic name
- LORATADINE
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- d778c4d2-184a-4dc8-9351-66d81d0618f2
- SPL ID
- 48cbeb9b-de13-4330-97b2-f87fb7e26cb9
- Version
- 3
- Effective date
- 2026-05-28
- Source export date
- 2026-10-12
- 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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:39:15
| 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 | 211718 | derived:openfda.application_number |
| application number | ANDA211718 | openfda.application_number | |
| brand name | Loratadine | openfda.brand_name | |
| generic name | LORATADINE | openfda.generic_name | |
| manufacturer name | Preferred Pharmaceuticals Inc. | openfda.manufacturer_name | |
| ndc | package | 68788-8605-3 | openfda.package_ndc |
| ndc | package | 68788-8605-9 | openfda.package_ndc |
| ndc | package | 68788-8605-1 | openfda.package_ndc |
| ndc | package | 68788-8605-0 | openfda.package_ndc |
| ndc | package | 68788-8605-5 | openfda.package_ndc |
| ndc | product | 68788-8605 | openfda.product_ndc |
| ndc11 | package | 68788860500 | derived:openfda.package_ndc |
| ndc11 | package | 68788860503 | derived:openfda.package_ndc |
| ndc11 | package | 68788860509 | derived:openfda.package_ndc |
| ndc11 | package | 68788860505 | derived:openfda.package_ndc |
| ndc11 | package | 68788860501 | derived:openfda.package_ndc |
| rxcui | 311372 | openfda.rxcui | |
| spl id | 48cbeb9b-de13-4330-97b2-f87fb7e26cb9 | id | |
| spl set id | d778c4d2-184a-4dc8-9351-66d81d0618f2 | set_id | |
| unii | 7AJO3BO7QN | 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.