FDA label 0f0b6a1c-be77-40b6-b7be-2209f873891a

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: 138e7e95-0865-4b4d-bbdb-1e9700db4aa0
SPL ID: 0f0b6a1c-be77-40b6-b7be-2209f873891a
Version: 1
Effective date: 2014-12-17
Source export date: 2026-11-06
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/2026-11-06/bbdc0a42bf44145a63c3752991067bece7e2a518be6cc14943d33c4987faa012/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:06:38

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		0f0b6a1c-be77-40b6-b7be-2209f873891a	id
spl set id		138e7e95-0865-4b4d-bbdb-1e9700db4aa0	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 For external use only. 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 tissues other than tooth cavity • DO NOT SWALLOW to avoid irritation • do not use for more than 7 days • do not exceed recommended dosage Stop use and ask a dentist or doctor if irritation persists, inflammation develops, or if fever and infection develop.

Reported adverse events (FAERS/openFDA)#

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