4x Medicated Toothache and Gum Cream

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
4x Medicated Toothache and Gum Cream
Generic name
BENZOCAINE
Manufacturer
Kroger
Product type
HUMAN OTC DRUG
SPL set ID
a8c5090a-24f9-4e73-e053-2a95a90acca0
SPL ID
4395634c-5feb-c88b-e063-6394a90aee8f
Version
5
Effective date
2025-11-14
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:26:39
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Methemoglobinmia warning: use of this product may cause methemoglobinemia, a serious condition which must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue 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" anethetics Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2years of age Keep out of reach of children. In case of overdose, 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.