4x Medicated Toothache and Gum Gel

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 Gel
Generic name
BENZOCAINE
Manufacturer
Walgreens
Product type
HUMAN OTC DRUG
SPL set ID
a71c47de-d35d-49da-e053-2995a90a823c
SPL ID
437fce02-298e-bd09-e063-6294a90ac869
Version
6
Effective date
2025-11-13
Source export date
2026-08-08
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/fb2175520ba436c0a81d623fd2a743c12c69c2188c898ffb9cc87c6b64d4a6cd/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:31:37
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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 ti reduces the amount of oxygen in teh 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" anesthetics 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 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.