FDA label dd377be3-b78b-4dec-8522-41e0dcfe66b5

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID: 6edf5c1e-b857-441a-88af-a7d1e8ece446
SPL ID: dd377be3-b78b-4dec-8522-41e0dcfe66b5
Version: 1
Effective date: 2011-10-01
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:50:59

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		dd377be3-b78b-4dec-8522-41e0dcfe66b5	id
spl set id		6edf5c1e-b857-441a-88af-a7d1e8ece446	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Warnings : For external use only. Ask a doctor before use if pregnant or nursing. Avoid using near eyes, mouth, or mucous membranes. Keep out of reach of children. Do not use if tamper evident seal is broken. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.