FDA label 8e3e2cde-dac8-471b-a03d-97c99025aaeb
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
- 3f875c91-3eaa-4d99-a5e4-27604f5be5be
- SPL ID
- 8e3e2cde-dac8-471b-a03d-97c99025aaeb
- Version
- 2
- Effective date
- 2013-09-30
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:20:57
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 | 8e3e2cde-dac8-471b-a03d-97c99025aaeb | id | |
| spl set id | 3f875c91-3eaa-4d99-a5e4-27604f5be5be | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING The safe use of T-STAT (erythromycin) 2.0% Solution during pregnancy or lactation has not been established.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse conditions reported include dryness, tenderness, pruritis, desquamation, erythema, oiliness, and burning sensation. Irritation of the eyes has also been reported. A case of generalized urticarial reaction, possibly related to the drug, which required the use of systemic steroid therapy has been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.