Quality Choice

Manufacturer
Chain Drug Marketing Association, Inc.
Effective date
2025-10-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:39:16

Label at a glance#

ProductQuality Choice
Active ingredientBENZOCAINE
Label structure12 sections

Storage and handling

Other information store at room temperature 20-25º (68-77ºF) this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted. Do not use continuously.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Benzocaine 20%................................Oral pain reliever

OTC - PURPOSE SECTION

Uses

  • for the temporary relief of pain due for:
  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor
  • for teething
  • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness does not go away
  • swelling, rash or fever develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose or allergic reaction, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

Adults and children 2 years of age and olderRemove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of ageShould be supervised in the use of this product
Children under 2 years of ageDo not use

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25º (68-77ºF)
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted. Do not use continuously.

INACTIVE INGREDIENT SECTION

Inactive ingredient glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DOSAGE & ADMINISTRATION SECTION

Distributed by CDMA, INC

Novi, MI 48375

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9536295362

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN4
238910benzocaine 0.2 MG/MG Oral GelSCD4
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-299-42Quality Choice1 in 1 CARTONGEL14
83324-299-42Quality Choice11.9 g in 1 TUBEGEL11.94

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-29983324-299-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-03-27full-release2026-06-01 00:58:00

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality ChoiceBENZOCAINEChain Drug Marketing Association, Inc.24c3c4a3-bd76-198d-e063-6394a90ad45a2025-10-16WarningsExact identifier
ndc (package): 83324-299-42
ndc (product): 83324-299
ndc11 (package): 83324029942
spl id: 414fb186-8272-58da-e063-6394a90a7ac6
spl set id: 24c3c4a3-bd76-198d-e063-6394a90ad45a

Reported adverse events (FAERS/openFDA)#

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