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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact 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