FDA.reportPublic FDA data

Walgreens

Product NDC
0363-5337
11-digit product format
003635337
Labeler code
0363
Product ID
0363-5337_441e8e00-6237-a9d4-e063-6394a90a9929
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Walgreens
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-01
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
2026-12-31
Current FDA listing
Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-5337-19IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-5337-19IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-5337-19IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-5337-19IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-5337-19UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-5337-19UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-5337-19UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g

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
562785Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ef0eb2c-b614-44e2-b9b3-97b02c654977Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-5337-192025-06-10C16284748780-12cef2736-76aa-d83d-e063-dadaa90ab31f5820337 Walgreens Max Str Oral Anesthetic Paste
0363-5337-192025-01-30C16284748780-12cef2736-76aa-d83d-e063-dadaa90ab31f5820337 Walgreens Max Str Oral Anesthetic Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5337-19WalgreensMaximum Strength12 g in 1 TUBEPASTE, DENTIFRICE1214
0363-5337-19WalgreensMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
GELATININACTIVE INGREDIENT2G86QN327LWALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AWALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YWALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
PECTININACTIVE INGREDIENT89NA02M4RXWALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UWALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1
SACCHARININACTIVE INGREDIENTFST467XS7DWALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5337WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]10Current NDC, Legacy NDC, 2 package rows20230112_2ef0eb2c-b614-44e2-b9b3-97b02c654977.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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.af430cf4-f1b4-4b57-b8e3-87df96d655d32025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.2b089fec-cae3-4dc9-964d-d37f732a2f9f2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.6c137a93-4a34-4849-997f-bd0c572466ef2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.e8aa9709-e8f6-47a6-ab29-1fef2309786b2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562785benzocaine 20 % Oral PastePSN2ef0eb2c-b614-44e2-b9b3-97b02c65497714
562785benzocaine 0.2 MG/MG Oral PasteSCD2ef0eb2c-b614-44e2-b9b3-97b02c65497714
562785benzocaine 20 % Mucous Membrane PasteSY2ef0eb2c-b614-44e2-b9b3-97b02c65497714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-5337-19003635337191 TUBE in 1 CARTON (0363-5337-19) / 12 g in 1 TUBE1 tube2013-08-010000-00-00NoNoCurrent