Mouth Sore Relief Professional Strength

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)

Brand name
Mouth Sore Relief Professional Strength
Generic name
BENZOCAINE
Manufacturer
CVS Pharmacy
Product type
HUMAN OTC DRUG
SPL set ID
1b7209f6-8368-47fa-8df2-b049613b8c1b
SPL ID
4005a1a1-f3aa-bd0f-e063-6394a90a1a61
Version
24
Effective date
2025-09-30
Source export date
2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:12:05
Harmonized routes table
Harmonized routes
ORAL

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

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can oocur even if you have use this product before. stop ise and seek immediate medical attention if you or a child in you care develops: palre, gray, or blue colored skin (cyanosis) headache rapid heart rate shotness of breath dizziness or lightheadedness fatique or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics Do not use: for teething in children under 2 years of age When using this product do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; f swelling, rash, of fever develops, see your dentist or doctor promptly. Keep out of reach of children . If more than used for pain is accidentally 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.