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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.872365ca-0c6b-550a-e053-2a91aa0ab25a2024-06-14WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser SpearmintSODIUM PERBORATE MONOHYDRATEVintage Brands Limited7ac6c649-758f-4128-9920-466c0967b86a2024-05-21WarningsExact identifier
application number: M022
SensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC9e8e7b9f-3ccd-4935-b886-93f3a5045b672024-05-15WarningsExact identifier
application number: M022
Sensodyne Extra WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC1ed4a62b-f1d3-4740-8150-b94e023987402024-05-15WarningsExact identifier
application number: M022
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsExact identifier
application number: M022
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
application number: M022
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
application number: M022
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
application number: M022
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLFamily Dollar (FAMILY WELLNESS)7806fac7-736e-44b0-baa2-42feb72374172024-03-27WarningsExact identifier
application number: M022
SucretsDYCLONINE HCL, MENTHOL, AND PECTINInsight Pharmaceuticals LLC2a2839ea-11d3-4390-930d-0da912a9c6f52024-03-20WarningsExact identifier
application number: M022
Sucrets Sore Throat Wild CherryDYCLONINE HYDROCHLORIDEInsight Pharmaceuticals LLCda4967c7-ee18-42e7-8c97-8919f3bb1b7d2024-03-20WarningsExact identifier
application number: M022
NATEAN Clean plus Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcea6f992-8a44-4eb8-baea-97b7b181b2272024-03-19WarningsExact identifier
application number: M022
NATEAN Clean and WhitenSODIUM FLUORIDEHaleon US Holdings LLC71b95962-2693-49f5-94d2-f2a035b5e0c82024-03-19WarningsExact identifier
application number: M022
SENSODYNE Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
application number: M022
SENSODYNE Sensitivity Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
application number: M022
Sensodyne True whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC671f8f45-389c-4375-be43-f5500ee21a0e2024-03-07WarningsExact identifier
application number: M022
Sensodyne Pronamel Strong and Bright Enamel MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCbe1ae382-0e01-4db8-90d7-fdadec2ff8612024-03-06WarningsExact 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