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 15 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Sensitive Whitening TPSODIUM FLUORIDETargetab9a129e-337b-31fe-e053-2995a90ac6912025-11-14WarningsExact identifier
application number: M022
Signature Care Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83225fe5-0490-eb4b-e053-2a91aa0a68792025-11-14WarningsExact identifier
application number: M022
Rite Aid Extra WhiteningFLUORIDERite Aidefe2c6c1-b8c6-4a52-b3c6-c9bfca4505702025-11-14WarningsExact identifier
application number: M022
Sound Body Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEBig Lots Stores, Inc.81a0a712-76e1-133f-e053-2a91aa0a001a2025-11-14WarningsExact identifier
application number: M022
Top Care Enamel GuardFLUORIDETOPCO Assoc. LLC8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c2025-11-14WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales24715cc7-cf02-4ea0-a491-2a111ad3660e2025-11-14WarningsExact identifier
application number: M022
Kroger Enamel Protection Sensitive Gentle WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEKroger Company82b9a954-2a53-ac56-e053-2991aa0abd0e2025-11-13WarningsExact identifier
application number: M022
Sensitive Extra WhiteningSODIUM FLUORIDEPublix Super Market16eddce3-03e4-4c0e-e063-6294a90ae94d2025-11-13WarningsExact identifier
application number: M022
Pronamel Repair WhiteningPRONAMEL REPAIR WHITENINGPublix Super Market Inc16ee2625-3641-205d-e063-6394a90a742f2025-11-13WarningsExact identifier
application number: M022
Rite Aid Maximum StrengthBENZOCAINERite Aid340ccdab-0a02-454c-8d44-ced5667276ab2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINECVSa7572c4f-089b-0e80-e053-2a95a90a0ddf2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEWalgreensad509f2a-05de-6c77-e053-2995a90ae5262025-11-13WarningsExact identifier
application number: M022
TopCare Oral Pain Relief Maximum StrengthBENZOCAINETopco Associates LLC835fb6ac-dbb7-5566-e053-2991aa0af5e22025-11-13WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEWalgreensa71c47de-d35d-49da-e053-2995a90a823c2025-11-13WarningsExact identifier
application number: M022
4X Medicated Toothache and Gum GelBENZOCAINEWalmarta471a858-edbf-c31e-e053-2995a90a71562025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum CreamBENZOCAINERite Aid996fdbeb-1fe3-77b6-e053-2995a90a25c72025-11-13WarningsExact identifier
application number: M022
Topco 4x Medicated Toothache and Gum GelBENZOCAINETopCareb463ea94-08a9-ca5d-e053-2a95a90a224b2025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum GelBENZOCAINERite Aid99703bf4-f169-5e05-e053-2995a90afab42025-11-13WarningsExact identifier
application number: M022
3X Medicated Mouth Sore GelBENZOCAINERite Aid997064c9-24bb-7fb1-e053-2995a90ace7c2025-11-13WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC8d187823-7e56-441b-8bca-8f03e7bb07c72025-11-12WarningsExact 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