FDA.reportPublic FDA data

Pearson Topical Anesthetic

Product NDC
43305-0003
11-digit product format
433050003
Labeler code
43305
Product ID
43305-0003_2bd90e79-7966-3bf5-e063-6394a90a7aef
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Pearson Dental Supplies INC.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-01
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
Pearson 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 · 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
af430cf4-f1b4-4b57-b8e3-87df96d655d3Available 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
43305-0003-3Pearson Topical Anesthetic30 g in 1 JARGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43305-0003PEARSON TOPICAL ANESTHETIC (BENZOCAINE) GEL [PEARSON DENTAL SUPPLIES INC.]3Current NDC, 1 package rows20250119_af430cf4-f1b4-4b57-b8e3-87df96d655d3.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 9 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wintergreen PeppermintPOTASSIUM NITRATE, SODIUM FLUORIDETwice Twice LLC7b7beec2-e070-4102-a2a4-68c332fc9fb32026-01-19WarningsExact identifier
application number: M022
GuruNanda SensitivePOTASSIUM NITRATEGURUNANDA, LLC3ef0d3d4-fd42-0181-e063-6394a90af09c2026-01-19WarningsExact identifier
application number: M022
Up and Up AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation386ee9f9-598e-ad00-e063-6394a90aeb462026-01-19WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company4a8f1d2f-b326-46d2-8914-d65ccc409edf2026-01-18WarningsExact identifier
application number: M022
Colgate Sensitive WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company3b656928-af58-4ee9-8fb8-360688eb9bf32026-01-13WarningsExact identifier
application number: M022
Colgate Sensitive Enamel HealthPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companya50d4259-8a79-417e-b381-72c7a8ec04182026-01-13WarningsExact identifier
application number: M022
Walgreens Sensitive Enamel RepairSODIUM FLUORIDEWalgreens41d6384d-695b-b60b-e063-6394a90aa0b92026-01-09WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLHY-VEE, INC47f738cc-7968-cc07-e063-6294a90af7ab2026-01-09WarningsExact identifier
application number: M022
CVS Health Clinical White Stain ProtectorSODIUM FLUORIDECVS Pharmacy41d5c3a9-abe5-5528-e063-6294a90ada792026-01-09WarningsExact identifier
application number: M022
CVS Health Sensitive Enamel RepairSODIUM FLUORIDECVS41d547b3-2feb-8e83-e063-6294a90ae3cd2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive Prevent and RepairPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companye67410dc-a671-4611-8af1-097be071cd1c2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive plus WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company2092c747-e025-47a9-9e54-731631d3c8312026-01-09WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2e7fbf9d-553c-c7bf-e063-6294a90a5f792026-01-08WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.47e2650f-4f50-8d85-e063-6394a90a1ddc2026-01-08WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2b4b22e9-a03b-fb8f-e063-6394a90a87472026-01-08WarningsExact identifier
application number: M022
Crest 3D White AdvancedSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf3aa9a59-b4d4-05d9-e053-2995a90a0aea2026-01-08Exact identifier
application number: M022
Oral B Plaque Defense Special Care Oral RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd503fad5-a378-0e60-e053-2a95a90abe652026-01-08WarningsExact identifier
application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All DayCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd5f69341-b659-c74a-e053-2a95a90a317e2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Breath Purify and Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd71ed31f-cc33-2fc3-e053-2995a90ad39b2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health ClinicalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company0a295ee0-55c2-4f21-8f0a-70efc0e516942026-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNaf430cf4-f1b4-4b57-b8e3-87df96d655d33
238910benzocaine 0.2 MG/MG Oral GelSCDaf430cf4-f1b4-4b57-b8e3-87df96d655d33
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYaf430cf4-f1b4-4b57-b8e3-87df96d655d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43305-0003-34330500030330 g in 1 JAR (43305-0003-3) 30 g2018-11-01NoNoCurrent