FDA.reportPublic FDA data

Walgreens

Product NDC
0363-5335
Requested package NDC
0363-5335-51
11-digit product format
003635335
Labeler code
0363
Product ID
0363-5335_f1ffc068-9953-5382-e053-2995a90a1cd1
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-01-10
Marketing end
0000-00-00
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
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-53350363-5335-51IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-5335-512025-01-30C16284748780-12cef2736-81c3-d83d-e063-dadaa90ab31fWalgreens Professional Str Mouth Sore Relief Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5335-51WalgreensSevere Oral Pain Reliever1 in 1 BLISTER PACKLIQUID110
0363-5335-51WalgreensSevere Oral Pain Reliever14.17 g in 1 BOTTLE, WITH APPLICATORLIQUID14.1710

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
BENZOININACTIVE INGREDIENTL7J6A1NE81WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
OLETH-10INACTIVE INGREDIENTJD797EF70JWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
RICINUS COMMUNIS SEEDINACTIVE INGREDIENT7EK4SFN1TXWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY6WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1
WATERINACTIVE INGREDIENT059QF0KO0RWALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5335WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]10Legacy NDC, 2 package rows20230112_4fa350ce-720e-4949-8376-e90f0a0f2d66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN4fa350ce-720e-4949-8376-e90f0a0f2d6610
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD4fa350ce-720e-4949-8376-e90f0a0f2d6610
308657benzocaine 20 % Mucous Membrane Topical SolutionSY4fa350ce-720e-4949-8376-e90f0a0f2d6610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-5335-51003635335511 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (0363-5335-51) > 14.17 g in 1 BOTTLE, WITH APPLICATOR2012-01-100000-00-00NoNoCurrent