FDA.reportPublic FDA data

Walgreens Mouth Sore Relief

Product NDC
0363-5334
11-digit product format
003635334
Labeler code
0363
Product ID
0363-5334_3c30f23d-25d3-0a60-e063-6394a90a5328
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-31
Substance
BENZOCAINE
Active strength
200 mg/mL
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
Walgreens Mouth Sore Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/mL

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
253d7ea2-e48e-c7d7-e063-6394a90ae001Available 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
0363-5334-00Walgreens Mouth Sore Relief1 in 1 BLISTER PACKLIQUID14
0363-5334-00Walgreens Mouth Sore Relief14.7 mL in 1 BOTTLELIQUID14.74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5334WALGREENS MOUTH SORE RELIEF (BENZOCAINE) LIQUID [WALGREENS]3Current NDC, 2 package rows20250124_253d7ea2-e48e-c7d7-e063-6394a90ae001.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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
application number: M022
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
application number: M022
SEXYTEETH CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
application number: M022
Gingicaine Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
application number: M022
3ECARE Dual formula WhiteningToothpaste RefillSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.501df1c7-4884-bb39-e063-6294a90aaf6a2026-04-23WarningsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
application number: M022
EverSmile AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
application number: M022
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
application number: M022
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
application number: M022
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsExact identifier
application number: M022
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN253d7ea2-e48e-c7d7-e063-6394a90ae0014
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD253d7ea2-e48e-c7d7-e063-6394a90ae0014
308657benzocaine 20 % Mucous Membrane Topical SolutionSY253d7ea2-e48e-c7d7-e063-6394a90ae0014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-5334-00003635334001 BOTTLE in 1 BLISTER PACK (0363-5334-00) / 14.7 mL in 1 BOTTLE1 bottle2024-12-01NoNoCurrent