FDA label 0fcb1b45-c04e-310a-e063-6294a90ab56d
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
- 2c10a7e0-4ae2-0432-e054-00144ff88e88
- SPL ID
- 0fcb1b45-c04e-310a-e063-6294a90ab56d
- Version
- 9
- Effective date
- 2024-01-01
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:31:50
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 | 0fcb1b45-c04e-310a-e063-6294a90ab56d | id | |
| spl set id | 2c10a7e0-4ae2-0432-e054-00144ff88e88 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Anaphylactic deaths have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treatment with the appropriate agents (e.g., epinephrine, antihistamines, and corticosteroids) should be administered.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.