FDA.reportPublic FDA data

BencoCaine Topical Anesthetic

Product NDC
66975-355
11-digit product format
669750355
Labeler code
66975
Product ID
66975-355_2b3a32cd-95ba-7651-e063-6394a90a3e38
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Benco Dental
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-27
Substance
BENZOCAINE
Active strength
200 mg/g
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
BencoCaine Topical Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238910Internal RxNorm lookup
1541816Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6e25b54-4734-4769-9d1e-2d1187fdae19Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-355-30BencoCaine Topical Anesthetic30 g in 1 JARGEL305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PBENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-355BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]5Current NDC, Legacy NDC, 1 package rows20250110_b6e25b54-4734-4769-9d1e-2d1187fdae19.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 41 · 818 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
application number: M022
Quality ChoiceBENZOCAINEChain Drug Marketing Association, Inc.24c3c4a3-bd76-198d-e063-6394a90ad45a2025-10-16WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLCardinal Healthb84203bd-23e9-427d-83d8-f4c88266e23c2025-10-14WarningsExact identifier
application number: M022
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCe8a62f24-1db6-45fb-b6e1-5e57103f82bc2025-10-14WarningsExact identifier
application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINTPOTASSIUM NITRATE, SODIUM FLUORIDEAshtel Studios, Inc.bc74d2a6-fe34-44cf-b015-70ed4d47c9332025-10-13WarningsExact identifier
application number: M022
Listerine Essential CareSODIUM MONOFLUOROPHOSPHATEKenvue Brands LLC90b5c3d8-baa4-44ab-8f73-e177007f02192025-10-10WarningsExact identifier
application number: M022
Anesgerm LA MUELA Fast Pain ReliefBENZOCAINE 20%Germa Products, LLCbf7842a2-9c0b-3fc3-e053-2995a90a36c12025-10-10WarningsExact identifier
application number: M022
Aftaseptic Instant Pain ReliefSALISYLIC ACID 1%Germa Products, LLCbeb32fba-503a-f5e5-e053-2a95a90a57e52025-10-10WarningsExact 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
Vicks VapoCool Sore ThroatBENZOCAINE AND MENTHOLThe Procter & Gamble Manufacturing Company8749824b-6d04-430d-e053-2995a90a2db82025-10-06WarningsExact identifier
application number: M022
Vicks VapoCool SEVEREMENTHOLThe Procter & Gamble Manufacturing Companyc77f8878-5eef-b006-e053-2a95a90a18662025-10-03WarningsExact identifier
application number: M022
Vicks VapoCOOL SEVEREMENTHOLThe Procter & Gamble Manufacturing Company042b6ea0-baf3-52d2-e063-6394a90ac6fb2025-10-03WarningsExact identifier
application number: M022
Equate Glistening MintSODIUM FLUORIDEWalmart Inc.39ff21ee-a362-014e-e063-6294a90a0d912025-10-03WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1541816BencoCaine 20 % Oral GelPSNb6e25b54-4734-4769-9d1e-2d1187fdae195
238910benzocaine 20 % Oral GelPSNb6e25b54-4734-4769-9d1e-2d1187fdae195
1541816benzocaine 0.2 MG/MG Oral Gel [Bencocaine]SBDb6e25b54-4734-4769-9d1e-2d1187fdae195
238910benzocaine 0.2 MG/MG Oral GelSCDb6e25b54-4734-4769-9d1e-2d1187fdae195
1541816Bencocaine 20 % Oral GelSYb6e25b54-4734-4769-9d1e-2d1187fdae195
1541816Bencocaine 200 MG/GM Topical Oral GelSYb6e25b54-4734-4769-9d1e-2d1187fdae195
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYb6e25b54-4734-4769-9d1e-2d1187fdae195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66975-355-306697503553030 g in 1 JAR (66975-355-30) 30 g2018-06-010000-00-00NoNoCurrent