Home NDC 0363-5337 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-5337-19 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-5337-19 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-5337-19 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-5337-19 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-5337-19 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-5337-19 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-5337-19 U Excluded because listing certification expired 0efc9e666f02…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 Ingredient Strength BENZOCAINE 20 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562785 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-5337-19 WalgreensMaximum Strength 12 g in 1 TUBE PASTE, DENTIFRICE 12 14 0363-5337-19 WalgreensMaximum Strength 1 in 1 CARTON PASTE, DENTIFRICE 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZOCAINE ACTIVE INGREDIENT U3RSY48JW5 WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 BENZOCAINE ACTIVE MOIETY U3RSY48JW5 WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 METHYL SALICYLATE INACTIVE INGREDIENT LAV5U5022Y WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 PECTIN INACTIVE INGREDIENT 89NA02M4RX WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1 SACCHARIN INACTIVE INGREDIENT FST467XS7D WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-5337 WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS] 10 Current NDC, Legacy NDC, 2 package rows 20230112_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 16 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GuruNanda Oxyfusion HYDROGEN PEROXIDE GURUNANDA, LLC 3be317b9-a5d8-b198-e063-6394a90af985 2025-11-11 Warnings Exact identifier application number: M022 GuruNanda Oral Pain Relief MENTHOL GURUNANDA, LLC 3b8f3562-0e46-bea4-e063-6294a90adb71 2025-11-11 Warnings Exact identifier application number: M022 TopCare Cherry Flavor PHENOL TOPCO ASSOCIATES, LLC 5d3f0610-deb4-4180-ae19-2c65ed2f368b 2025-11-10 Warnings Exact identifier application number: M022 Topcare Sore Throat Menthol Flavor PHENOL TOPCO ASSOCIATES LLC fb1f2c11-2508-4985-bae5-7d547bd6aa23 2025-11-10 Warnings Exact identifier application number: M022 Zilactin-B BENZOCAINE ASCENT CONSUMER PRODUCTS, INC 42eeb3d4-bac6-4e29-e063-6294a90a644d 2025-11-06 Warnings Exact identifier application number: M022 Zilactin Early Relief Cold Sore BENZYL ALCOHOL ASCENT CONSUMER PRODUCTS, INC 42ef8bfa-c4d9-01cf-e063-6394a90ac88a 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 106b6115-d043-4050-80c6-1d82456dea02 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 4c278122-2643-46bf-9e44-11985210a16e 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC fee9969d-ad1a-4f44-9741-a0a44c9e1128 2025-11-06 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE Target Corporation 0ddf9945-147d-4b25-98a6-4e9f12a4656f 2025-11-05 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. e6a312e5-17ac-46f0-8723-4e40eeecd69f 2025-11-04 Warnings Exact identifier application number: M022 PEROXY SHIELD MOUTH SORE 1.5% HYDROGEN PEROXIDE Dental Technologies, Inc. a72e433b-1b7d-4a0c-e053-2995a90a30c4 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ae628766-25b7-4b4f-abb8-a43faf2f44b9 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. 719743f9-21fc-4568-b879-acdfa4639464 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ff0695a1-1d7d-4b51-97fd-689e56d914fe 2025-11-04 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Family Dollar (FAMILY WELLNESS) f7edf75c-cdba-4dde-bfc5-a04af34759d3 2025-11-03 Warnings Exact identifier application number: M022 7 Select Oral Pain Maximum Strength Relief BENZOCAINE 7-ELEVEN, INC. f170a570-1c50-4b9a-be16-9b01bf5eaa74 2025-10-31 Warnings Exact identifier application number: M022 Oral Pain Relief BENZOCAINE AND BENZALKONIUM CHLORIDE Universal Distribution Center LLC 18520f9b-4d35-1e9c-e063-6294a90aaa39 2025-10-30 Warnings Exact identifier application number: M022 Iodent Oral Analgesic BENZOCAINE United Exchange Corp. 63902125-f8dc-0ada-e053-2991aa0a7ce5 2025-10-30 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE BETTER LIVING BRANDS, LLC 3bded237-4d2c-4b38-bedc-267fdc374194 2025-10-29 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-5337-19 00363533719 1 TUBE in 1 CARTON (0363-5337-19) / 12 g in 1 TUBE 1 tube 2013-08-01 0000-00-00 No No Current