warnings
Warnings When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry. This is to be expected.
Naloxone Hydrochloride
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
- Naloxone Hydrochloride
- Generic name
- NALOXONE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 8091a73d-9ecd-4578-a57b-5d85a2c5a16a
- SPL ID
- 38da0633-039b-450a-9b04-592db2238396
- Version
- 12
- Effective date
- 2026-08-25
- Source export date
- 2026-11-06
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/b433ab6a44616055e476a7876dbdd70a7f81f656e17ee28dc50dad20e67316bd/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
- Import run
- 20261106T075659Z
- Imported at
- 2026-11-06 09:26:43
| Harmonized routes |
|---|
| NASAL |
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 | 217992 | derived:openfda.application_number |
| application number | ANDA217992 | openfda.application_number | |
| brand name | Naloxone Hydrochloride | openfda.brand_name | |
| generic name | NALOXONE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Amneal Pharmaceuticals LLC | openfda.manufacturer_name | |
| ndc | package | 69238-2104-1 | openfda.package_ndc |
| ndc | package | 69238-2104-7 | openfda.package_ndc |
| ndc | product | 69238-2104 | openfda.product_ndc |
| ndc11 | package | 69238210401 | derived:openfda.package_ndc |
| ndc11 | package | 69238210407 | derived:openfda.package_ndc |
| rxcui | 1725059 | openfda.rxcui | |
| spl id | 38da0633-039b-450a-9b04-592db2238396 | id | |
| spl set id | 8091a73d-9ecd-4578-a57b-5d85a2c5a16a | set_id | |
| unii | F850569PQR | 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.