Quality Choice

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
Quality Choice
Generic name
BENZOCAINE
Manufacturer
Chain Drug Marketing Association, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
24c3c4a3-bd76-198d-e063-6394a90ad45a
SPL ID
414fb186-8272-58da-e063-6394a90a7ac6
Version
4
Effective date
2025-10-16
Source export date
2026-11-06
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/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:01:20
Harmonized routes table
Harmonized routes
TOPICAL

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 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 blood. This can occur even I you have used this product before. Stop use and seek immediate medical attention if you are a child in your care develops: pale, gay, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheartedness fatigue or lack of energy ​Allergy Alert: do not use this product if you have a history of allergy to local anethetics as procaine, bucaine, benzocaine or other "caine" anesthetics.

Reported adverse events (FAERS/openFDA)#

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