FDA.reportPublic FDA data

FDA label 6a4d8151-f291-366b-e053-2991aa0a1359

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
5fb933b5-c1df-269c-a03c-d42ea76918b0
SPL ID
6a4d8151-f291-366b-e053-2991aa0a1359
Version
4
Effective date
2018-04-20
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:53

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 Suction Swab with Perox-A-Mint Solution: Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain or redness persists or worsens. Suction Toothbrush with Antiplaque Solution Stop use and ask a dentist if Gingivitis, bleeding or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Reported adverse events (FAERS/openFDA)#

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