FDA label b97160dd-c1f6-4ae6-9eb9-8441e04b793e
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
- SPL set ID
- b311db87-f105-4875-1c8a-d87cf11588c5
- SPL ID
- b97160dd-c1f6-4ae6-9eb9-8441e04b793e
- Version
- 3
- Effective date
- 2011-09-02
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:04:27
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 |
|---|---|---|---|
| spl id | b97160dd-c1f6-4ae6-9eb9-8441e04b793e | id | |
| spl set id | b311db87-f105-4875-1c8a-d87cf11588c5 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING Bone marrow hypoplasia including aplastic anemia and death has been reported following local application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings SEE BOXED WARNING. Discontinue promptly if sensitization or irritation occurs.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions Signs of local irritation with subjective symptoms of itching or burning, angioneurotic edema, urticaria, vesicular and maculopapular dermatitis have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. Similar sensitivity reactions to other materials in topical preparations may also occur. Blood dyscrasias have been reported in association with the use of chloramphenicol (see WARNINGS).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.