FDA label 2fad6e5c-cd3f-4180-9f19-c2ccbf3176d3

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: 5626aab5-52ff-442f-9441-8a4772bfc9b8
SPL ID: 2fad6e5c-cd3f-4180-9f19-c2ccbf3176d3
Version: 3
Effective date: 2012-09-11
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:12:33

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		2fad6e5c-cd3f-4180-9f19-c2ccbf3176d3	id
spl set id		5626aab5-52ff-442f-9441-8a4772bfc9b8	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: Canker Cover should not be used on children under 5 years old without consulting a physician. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness worsens; or if swelling, rash or fever develops, see doctor or dentist. Consult your physician if you are pregnant, breastfeeding or taking prescription drugs.

Reported adverse events (FAERS/openFDA)#

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