FDA.reportPublic FDA data

Rexall

Product NDC
55910-346
11-digit product format
559100346
Labeler code
55910
Product ID
55910-346_3c30c101-f57c-f3ba-e063-6394a90ac007
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Rexall
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
Substance
BENZOCAINE
Active strength
20 g/100mL
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
Rexall
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100mL

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
308657Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f6e2780-cfb7-4bef-9b7d-13cb80d8923eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-346-79RexallMaximum Strength14.7 mL in 1 BOTTLELIQUID14.711
55910-346-79RexallMaximum Strength1 in 1 CARTONLIQUID111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5REXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5REXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHREXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GREXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDREXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAREXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQREXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYREXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-346REXALL MAXIMUM STRENGTH (BENZOCAINE) LIQUID [REXALL]10Current NDC, Legacy NDC, 2 package rows20250119_8f6e2780-cfb7-4bef-9b7d-13cb80d8923e.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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraspeticMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.2b1808b2-2574-4ab8-a762-5733251848ce2024-10-25WarningsExact identifier
application number: M022
Chloraseptic Warming Sore ThroatPHENOLPrestige Brands Holdings, Inc.a197fab2-70ce-4a6c-9add-29d7368a75c52024-10-25WarningsExact identifier
application number: M022
Gly-OxideCARBAMIDE PEROXIDEMedtech Products Inc.086a0b82-e947-41c9-89e7-ba06483960c92024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.b30e4b32-89dd-4e53-81d5-1415105361d42024-10-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEEfficient Laboratories Inc.28c5a993-fb5f-4091-af15-32ccae4b9a7d2024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive FreshmintPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.7e715bb9-666e-4de4-ba70-1c84f52434432024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.2daf18a3-f71e-4585-8128-4663eff7eb6d2024-10-14WarningsExact identifier
application number: M022
Anadent Kanka GelBENZOCAINEBELMORA LLCe0f73d78-5db1-43b4-8f58-e5410ca4560f2024-10-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLNavajo Manufacturing Company Inc.f5f26e2f-8a1f-4687-e053-2a95a90ae3782024-10-03WarningsExact identifier
application number: M022
Colgate Great Regular FlavorSODIUM MONOFLUOROPHOSPHATENavajo Manufacturing Company Inc.f89bf259-b738-8229-e053-6394a90a0c592024-10-03WarningsExact identifier
application number: M022
Colgate Total SF Clean MintSTANNOUS FLUORIDENavajo Manufacturing Company Inc.f71c53e0-e2dd-16f9-e053-6394a90accff2024-10-03WarningsExact identifier
application number: M022
Crest Pro HealthCETYLPYRIDINIUM CHLORIDENavajo Manufacturing Company Inc.65bf17a9-21ad-27cb-e053-2991aa0afc402024-10-02WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening AdvancedPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC94e07979-943b-45bb-8e2b-90d686f3692e2024-09-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Advanced PlusPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC6eb304dd-2a24-4fa0-9d39-71264e88dd162024-08-29WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcfda7efa-86fa-470d-a79f-81907e31778a2024-08-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Bubble TwistSODIUM FLUORIDEHaleon US Holdings LLCe403529a-0fac-4dab-b75c-46906add096b2024-08-13WarningsExact identifier
application number: M022
Calcium Carbonate Assorted FlavorsANTACID TABLETSNuCare Pharmaceuticals,Inc.af10dfb6-fef3-3410-e053-2995a90a91302024-07-17WarningsExact identifier
application number: M022
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsExact identifier
application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE, SODIUM FLUORIDELidl US, LLCbaef7f15-8082-4e61-8c08-8beda8ad40c02024-07-03WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN8f6e2780-cfb7-4bef-9b7d-13cb80d8923e11
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD8f6e2780-cfb7-4bef-9b7d-13cb80d8923e11
308657benzocaine 20 % Mucous Membrane Topical SolutionSY8f6e2780-cfb7-4bef-9b7d-13cb80d8923e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-346-69559100346691 BOTTLE in 1 CARTON (55910-346-69) > 14.7 mL in 1 BOTTLE (55910-346-61) 1 bottle2015-01-130000-00-00NoNoCurrent
55910-346-79559100346791 BOTTLE in 1 CARTON (55910-346-79) / 14.7 mL in 1 BOTTLE1 bottle2023-02-01NoNoCurrent