FDA.reportPublic FDA data

Quality Choice Maximum Strength Oral Pain Relieving

Product NDC
63868-953
11-digit product format
638680953
Labeler code
63868
Product ID
63868-953_41629205-ee47-326e-e063-6294a90ab1ec
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE
Dosage form
GEL
Route
TOPICAL
Labeler
Chain Drug Marketing Association Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-31
Substance
BENZOCAINE
Active strength
20 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Quality Choice Maximum Strength Oral Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238910Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbde8e7f-85d8-4083-b01a-3a7e410a7747Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-02-07QC Maximum Strength Oral Analgesic 0.42oz 95362
2025-02-07QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-03-31QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-03-31QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-01-28QC Maximum Strength Oral Analgesic 0.42oz 95362
2022-01-28QC 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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYQUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BQUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-953QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]10Current NDC, Legacy NDC, 2 package rows20250210_dbde8e7f-85d8-4083-b01a-3a7e410a7747.zip

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 18 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Essential CareSODIUM MONOFLUOROPHOSPHATEKenvue Brands LLC90b5c3d8-baa4-44ab-8f73-e177007f02192025-10-10WarningsExact identifier
application number: M022
DuoCare Clinical Oral RinseCETYLPYRIDINIUM CHLORIDEMedline Industries, LP98e61cd5-7e29-7066-e053-2a95a90afa212025-10-10WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd40b756b7-ce1b-6482-e063-6294a90a04252025-10-09WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEGil Pharmaceutical Corp85053391-8d71-ab4f-e053-2991aa0a7e082025-10-09WarningsExact identifier
application number: M022
Listerine Gum Therapy Mouthwash Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC40a0bdf3-1698-1449-e063-6394a90ab13d2025-10-08WarningsExact identifier
application number: M022
Kalaya Breath RefreshMOUTHWASHAvaria Health and Beauty Corp750e99ff-72e4-3c2f-e053-2a91aa0ad5a02025-10-08WarningsExact identifier
application number: M022
Trader JoesSODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5%TRADER JOE'S COMPANY159abeba-6da2-2643-e063-6394a90a730d2025-10-08WarningsExact identifier
application number: M022
Family Wellness Oral Pain ReliefBENZOCAINE 20%FAMILY DOLLAR SERVICES INC105d87d6-9147-43d4-e063-6394a90a57ee2025-10-08WarningsExact identifier
application number: M022
Equate Glistening MintSODIUM FLUORIDEWalmart Inc.39ff21ee-a362-014e-e063-6294a90a0d912025-10-03WarningsExact identifier
application number: M022
Mouth Sore Relief Professional StrengthBENZOCAINECVS Pharmacy1b7209f6-8368-47fa-8df2-b049613b8c1b2025-09-30WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEFamily Dollar (FAMILY WELLNESS)9db73da2-5b70-41e6-bcf9-caa7f11420242025-09-29WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic LiquidCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47d7e1-b6ae-efd1-e063-6394a90a46022025-09-27WarningsExact identifier
application number: M022
Chloraseptic Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.d5d62f7a-8f92-4d42-a2fb-691f896f72fc2025-09-26WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEDextrum Laboratories Inc.3fa233dc-156c-1e95-e063-6294a90a8bbd2025-09-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEDextrum Laboratories Inc.cb027ab8-4175-4cc0-a73e-991dfb113df92025-09-23WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd3f872924-0c44-267b-e063-6394a90a1a672025-09-23WarningsExact identifier
application number: M022
Dental ReliefBENZOCAINECintas Corporation0f40f775-797e-43cf-88c9-00eea666494f2025-09-23WarningsExact identifier
application number: M022
Seavue Anti-caries GelSODIUM FLUORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4c6086-b96d-8fa4-e063-6294a90ad8002025-09-21WarningsExact identifier
application number: M022
Seavue Dental DesensitizerPOTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47f399-1a14-5264-e063-6394a90aeb1c2025-09-20WarningsExact identifier
application number: M022
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNdbde8e7f-85d8-4083-b01a-3a7e410a774711
238910benzocaine 0.2 MG/MG Oral GelSCDdbde8e7f-85d8-4083-b01a-3a7e410a774711
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYdbde8e7f-85d8-4083-b01a-3a7e410a774711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-953-11638680953111 TUBE in 1 CARTON (63868-953-11) / 11.76 g in 1 TUBE1 tube2013-05-310000-00-00NoNoCurrent