FDA.reportPublic FDA data

Rite Aid

Product NDC
11822-0345
11-digit product format
118220345
Labeler code
11822
Product ID
11822-0345_437fc201-e0df-b2d6-e063-6394a90a9d24
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Rite Aid
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
Marketing end
2027-01-01
Substance
BENZOCAINE
Active strength
20 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
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
Rite Aid
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g

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
340ccdab-0a02-454c-8d44-ced5667276abAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0345-1Rite AidMaximum Strength14.7 g in 1 BOTTLELIQUID14.715
11822-0345-7Rite AidMaximum Strength1 in 1 CARTONLIQUID115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5RITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5RITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHRITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TRITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0345RITE AID MAXIMUM STRENGTH (BENZOCAINE) LIQUID [RITE AID]13Current NDC, Legacy NDC, 2 package rows20250119_340ccdab-0a02-454c-8d44-ced5667276ab.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 23 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc9315bd7c-44db-42c8-a9df-aaaa66153c172025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc56185c5f-6f6c-4976-bf18-540b076d90a62025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc88cadb9e-17ab-44bb-b4fe-fcfd6b7334652025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf71b0ab5-0605-4807-b835-903e19aaf2a82025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN340ccdab-0a02-454c-8d44-ced5667276ab15
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD340ccdab-0a02-454c-8d44-ced5667276ab15
308657benzocaine 20 % Mucous Membrane Topical SolutionSY340ccdab-0a02-454c-8d44-ced5667276ab15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0345-11182203450114.7 g in 1 BOTTLE14.7 gHistorical
11822-0345-7118220345071 BOTTLE in 1 CARTON (11822-0345-7) / 14.7 g in 1 BOTTLE (11822-0345-1) 1 bottle2015-01-012027-01-01NoNoHistorical
11822-0345-9118220345091 BOTTLE in 1 CARTON (11822-0345-9) > 14.7 g in 1 BOTTLE (11822-0345-1) 1 bottle2015-01-010000-00-00NoNoCurrent