FDA.reportPublic FDA data

Quality Choice Maximum Strength Oral Pain Relieving

Manufacturer
Chain Drug Marketing Association Inc
Effective date
2025-10-17
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:39:30

Label at a glance#

ProductQuality Choice Maximum Strength Oral Pain Relieving
Active ingredientBENZOCAINE
Label structure12 sections

Storage and handling

Other information store at room temperature 20° to 25°C (68° to 77°F) 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

  • temporarily relieves pain due to:
  • 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 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 your child has a history of allergy to local anesthetics such as procaine, butacaine, 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 persists or worsens
  • 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 cases of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions

Adults and children 2 years of age and older.

Remove 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 age.Should be supervised in the use of this product.
Children under 2 years of age.Do not use.

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20° to 25°C (68° to 77°F)
  • 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 ingredients

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

DOSAGE & ADMINISTRATION SECTION

Distributed By C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in South Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9536295362

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN11
238910benzocaine 0.2 MG/MG Oral GelSCD11
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY11

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130635515953628GTIN-13: 0635515953628
EAN-13: 0635515953628
GTIN-12: 635515953628
UPC-A: 635515953628
GTIN storage (14 digits): 00635515953628		95362.1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-953-112025-02-07C16284748780-1d6a99b39-50ef-a426-e053-dadaa90af4c2QC Maximum Strength Oral Analgesic 0.42oz 95362
63868-953-112025-02-07C16284748780-1d6a99b39-50ef-a426-e053-dadaa90af4c2QC Maximum Strength Oral Analgesic 0.42oz 95362
63868-953-112022-03-31C16284748780-1d6a99b39-50ef-a426-e053-dadaa90af4c2QC Maximum Strength Oral Analgesic 0.42oz 95362
63868-953-112022-03-31C16284748780-1d6a99b39-50ef-a426-e053-dadaa90af4c2QC Maximum Strength Oral Analgesic 0.42oz 95362
63868-953-112022-01-28C16284748780-1d6a99b39-50ef-a426-e053-dadaa90af4c2QC Maximum Strength Oral Analgesic 0.42oz 95362
63868-953-112022-01-28C16284748780-1d6a99b39-50ef-a426-e053-dadaa90af4c2QC Maximum Strength Oral Analgesic 0.42oz 95362

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-953-11Quality Choice Maximum Strength Oral Pain Relieving11.76 g in 1 TUBEGEL11.7611
63868-953-11Quality Choice Maximum Strength Oral Pain Relieving1 in 1 CARTONGEL111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-953-11GM - Gram63868-9536f58de23-8df3-45da-8133-3a43ded309c612023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZOCAINEACTIVE MOIETYU3RSY48JW51
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-95363868-953-11

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PEPPERMINT OILAV092KU4JHIACT
BENZOCAINEU3RSY48JW5ACTIB
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-12-20full-release2026-06-01 00:54:43

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 Choice Maximum Strength Oral Pain RelievingBENZOCAINEChain Drug Marketing Association Incdbde8e7f-85d8-4083-b01a-3a7e410a77472025-10-17WarningsExact identifier
ndc (package): 63868-953-11
ndc (product): 63868-953
ndc11 (package): 63868095311
spl id: 41629205-ee47-326e-e063-6294a90ab1ec
spl set id: dbde8e7f-85d8-4083-b01a-3a7e410a7747

Reported adverse events (FAERS/openFDA)#

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