FDA label eab5a54e-d02c-c5cb-e053-2995a90a7b21

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: eab5a54e-d02b-c5cb-e053-2995a90a7b21
SPL ID: eab5a54e-d02c-c5cb-e053-2995a90a7b21
Version: 1
Effective date: 2022-10-10
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 05:31:45

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		eab5a54e-d02c-c5cb-e053-2995a90a7b21	id
spl set id		eab5a54e-d02b-c5cb-e053-2995a90a7b21	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 Allergy alert: do not use if you are allergic to eugenol (clove oil). When using this product use only in teeth with persistent throbbing pain avoid touching tissuers other than tooth cavity DO NOT SWALLOW to avoid irritation avoid contact with eyes. Do not use for more than 7 days more than the recommended dosage. Stop use and ask a dentist or doctor if irritation persists inflammation develops if fever and infection develop. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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