warnings
WARNINGS DO NOT USE if you have ever had an allergic reaction to this product or any of its ingredients
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
- NuCare Pharmaceuticals,Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 16f00a3a-0777-f70c-e063-6294a90a71c9
- SPL ID
- 4ece9297-a72e-a420-e063-6394a90ab367
- Version
- 3
- Effective date
- 2026-04-06
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:06
| 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 | 210722 | derived:openfda.application_number |
| application number | ANDA210722 | openfda.application_number | |
| brand name | Loratadine | openfda.brand_name | |
| generic name | LORATADINE | openfda.generic_name | |
| manufacturer name | NuCare Pharmaceuticals,Inc. | openfda.manufacturer_name | |
| ndc | package | 68071-3596-6 | openfda.package_ndc |
| ndc | package | 68071-3596-3 | openfda.package_ndc |
| ndc | package | 68071-3596-9 | openfda.package_ndc |
| ndc | product | 68071-3596 | openfda.product_ndc |
| ndc11 | package | 68071359603 | derived:openfda.package_ndc |
| ndc11 | package | 68071359609 | derived:openfda.package_ndc |
| ndc11 | package | 68071359606 | derived:openfda.package_ndc |
| rxcui | 311372 | openfda.rxcui | |
| spl id | 4ece9297-a72e-a420-e063-6394a90ab367 | id | |
| spl set id | 16f00a3a-0777-f70c-e063-6294a90a71c9 | 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.