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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore Mouth CleanserHYDROGEN PEROXIDEMeijer, Inc.c9c17224-9304-403a-b6a1-9c8bd94e3d942026-02-19Warnings, Adverse reactionsExact identifier
application number: M022
AQUAFRESH CAVITY PROTECTIONSODIUM FLUORIDEHaleon US Holdings LLC5484999c-8e6f-430d-99a5-6893a24894672026-02-16WarningsExact identifier
application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
application number: m022
Sore Mouth CleanserHYDROGEN PEROXIDEWalgreen Co.33223589-4ff4-4e4e-96da-6fa2e4d0f1872026-02-12Warnings, Adverse reactionsExact identifier
application number: M022
PERIOSCIENCES SENSITIVE AO ProPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLCacca8964-b575-468c-8b40-514dfbf507782026-02-09WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLRetail Business Services, LLCd46546d0-c6df-431a-8ab0-bc5013c084d72026-02-06Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)e19228e9-6f87-456e-a222-f979a234d5892026-02-06WarningsExact identifier
application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
application number: M022
Sootheez Strawberry LemonadePECTINPrimrose Candy Co.49e2b303-1018-cd13-e063-6394a90ae3002026-02-02WarningsExact identifier
application number: M022
Sootheez Berry LemonadePECTINPrimrose Candy Co.49cee56f-c45f-6c79-e063-6294a90a5f8f2026-02-01WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDERite Aid Corporation294418aa-640d-42be-ad07-de31da7a7ccc2026-01-30Warnings, Adverse reactionsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company866067b9-3dce-492d-ae99-1b807ecd56ff2026-01-22WarningsExact identifier
application number: M022
Family Wellness Pain ReliefBENZOCAINE 20%FAMILY DOLLAR (Family Wellness)92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea2026-01-21WarningsExact identifier
application number: M022
Crest Pro-Health All Day Clean BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company48eaca4c-19c2-2dd2-e063-6394a90a3e082026-01-21WarningsExact identifier
application number: M022
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINEUniversal Distribution Center LLCe276ba37-46fb-4ed9-9ee1-c08a2a89704a2026-01-20WarningsExact identifier
application number: M022
Equate Orasol20% BENZOCAINEWAL-MART STORES INC.08404780-8252-4484-b1c3-8970803f74f82026-01-19WarningsExact identifier
application number: M022
Equate Healthy MouthCPC 0.05% ANTIPLAQUE/ANTI-GINGIVITISWalmart, Inc.1cc1f6fd-67d4-b314-e063-6294a90ab9952026-01-19WarningsExact 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