FDA.reportPublic FDA data

Mouth Sore Relief

Product NDC
59779-830
11-digit product format
597790830
Labeler code
59779
Product ID
59779-830_4005a1a1-f3aa-bd0f-e063-6394a90a1a61
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-01
Substance
BENZOCAINE
Active strength
200 mg/g
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
Mouth Sore Relief
Brand name suffix
Professional Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

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
1b7209f6-8368-47fa-8df2-b049613b8c1bAvailable 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
59779-830-38Mouth Sore ReliefProfessional Strength1 in 1 BLISTER PACKLIQUID124
59779-830-38Mouth Sore ReliefProfessional Strength14.7 g in 1 BOTTLE, WITH APPLICATORLIQUID14.724
59779-830-48Mouth Sore ReliefProfessional Strength1 in 1 BLISTER PACKLIQUID124
59779-830-48Mouth Sore ReliefProfessional Strength14.7 g in 1 BOTTLELIQUID14.724

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
BENZOCAINEACTIVE MOIETYU3RSY48JW5MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
ALCOHOLINACTIVE INGREDIENT3K9958V90MMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
BENZOININACTIVE INGREDIENTL7J6A1NE81MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
MENTHOLINACTIVE INGREDIENTL7T10EIP3AMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
OLETH-10INACTIVE INGREDIENTJD797EF70JMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
RICINUS COMMUNIS SEEDINACTIVE INGREDIENT7EK4SFN1TXMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY6MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14
WATERINACTIVE INGREDIENT059QF0KO0RMOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-830MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]22Current NDC, Legacy NDC, 4 package rows20250119_1b7209f6-8368-47fa-8df2-b049613b8c1b.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 4 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Mint JulepGINGICAINE GEL, MINT JULEP FLABVORGingi-Pak a Division of the Belport6285fe10-08ba-8044-e053-2991aa0a8e8b2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Chocolate MintGINGICAINE GEL, CHOCOLATE MINT FLAVORGingi-Pak a Division of the Belport6285c4f2-c139-49a9-e053-2991aa0a2b032026-06-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Bellport Company, Inc. dba Gingi-Pakf5dd8fa8-0b6a-5a30-e053-2995a90ad1942026-06-26WarningsExact identifier
application number: M022
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
application number: M022
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
application number: M022
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
application number: M022
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
application number: M022
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsExact identifier
application number: M022
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
application number: M022
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
application number: M022
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
application number: M022
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
application number: M022
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
application number: M022
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
application number: M022
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN1b7209f6-8368-47fa-8df2-b049613b8c1b24
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD1b7209f6-8368-47fa-8df2-b049613b8c1b24
308657benzocaine 20 % Mucous Membrane Topical SolutionSY1b7209f6-8368-47fa-8df2-b049613b8c1b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-830-38597790830381 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (59779-830-38) / 14.7 g in 1 BOTTLE, WITH APPLICATOR2011-04-190000-00-00NoNoCurrent
59779-830-48597790830481 BOTTLE in 1 BLISTER PACK (59779-830-48) / 14.7 g in 1 BOTTLE1 bottle2011-04-190000-00-00NoNoCurrent