FDA.reportPublic FDA data

Rite Aid

Product NDC
11822-5340
11-digit product format
118225340
Labeler code
11822
Product ID
11822-5340_441e2a5a-c461-451a-e063-6394a90ace77
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Rite Aid
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Marketing end
2026-11-30
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
Professional 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
31ce0cb3-a43a-41bd-b030-21f91f2b1368Available 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
11822-5340-1Rite AidProfessional Strength14.17 g in 1 BOTTLE, WITH APPLICATORLIQUID14.1719
11822-5340-9Rite AidProfessional Strength1 in 1 BLISTER PACKLIQUID119

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5RITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5RITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
BENZOIN RESININACTIVE INGREDIENTGK21SBA74RRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ARITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
OLETH-10INACTIVE INGREDIENTJD797EF70JRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
RICINUS COMMUNIS SEEDINACTIVE INGREDIENT7EK4SFN1TXRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4RITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY6RITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1
WATERINACTIVE INGREDIENT059QF0KO0RRITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5340RITE AID PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [RITE AID]18Current NDC, Legacy NDC, 2 package rows20250119_31ce0cb3-a43a-41bd-b030-21f91f2b1368.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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN31ce0cb3-a43a-41bd-b030-21f91f2b136819
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD31ce0cb3-a43a-41bd-b030-21f91f2b136819
308657benzocaine 20 % Mucous Membrane Topical SolutionSY31ce0cb3-a43a-41bd-b030-21f91f2b136819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-5340-11182253400114.17 g in 1 BOTTLE, WITH APPLICATOR14.17 gHistorical
11822-5340-8118225340081 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (11822-5340-8) > 14.17 g in 1 BOTTLE, WITH APPLICATOR (11822-5340-1) 2014-01-010000-00-00NoNoCurrent
11822-5340-9118225340091 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (11822-5340-9) / 14.17 g in 1 BOTTLE, WITH APPLICATOR (11822-5340-1) 2014-01-012026-11-30NoNoHistorical