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 3 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact identifier
application number: M022
Freshness Coffee Toothpaste100gFRESHNESS COFFEE TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d79e9-2f0f-fa72-e063-6394a90a8dea2026-08-06WarningsExact identifier
application number: M022
Freshness Flower Rose Toothpaste100gFRESHNESS FLOWER ROSE TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d7f5e-55e0-4fd2-e063-6294a90a92b62026-08-06WarningsExact identifier
application number: M022
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
application number: M022
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
application number: M022
Dental system starter kitUS CONVENIENCE KIT (718907)Dyson Technology Limited5355b79b-711f-1a4a-e063-6394a90afc4b2026-06-30WarningsExact identifier
application number: M022
Anticavity and sensitive peppermint907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINTDyson Technology Limited5332ab71-d994-39cf-e063-6294a90a0d982026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
application number: M022
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
application number: M022
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact identifier
application number: M022
GingiCaine gel, CherryGINGICAINE GEL, CHERRY FLAVORGingi-Pak a Division of the Belport6274d92e-c4e9-34fd-e053-2991aa0ae6042026-06-29WarningsExact 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