Home NDC 0363-0316 NBE Anbesol
Product NDC 0363-0316
11-digit product format 003630316
Labeler code 0363
Product ID 0363-0316_441e7c47-f347-a262-e063-6394a90ae697
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route ORAL
Labeler Walgreens
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-30
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0363-0316 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-0316 0363-0316-69 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 NBE Anbesol
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0316-69 NBE Anbesol 1 in 1 CARTON GEL 1 6 0363-0316-69 NBE Anbesol 9 g in 1 TUBE GEL 9 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0316 NBE ANBESOL (BENZOCAINE) GEL [WALGREENS] 4 Current NDC, Legacy NDC, 2 package rows 20250119_dd2a3125-32f8-5fff-e053-2995a90ac720.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 30 of 39 · 779 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Benzo-Jel BENZOCAINE Henry Schein Inc. ba49a18d-8568-421b-a495-8fee863c9757 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. c9b584d9-7407-445a-b084-926250af9f8e 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 4aa6eec8-394a-4ecb-8173-66561fd64913 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 25c99ae3-90f4-4a63-924d-f810b3ba6e60 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6 2025-01-03 Warnings Exact identifier application number: M022 Prevention Oncology Mouth Rinse GLYCERIN Prevention Health Sciences, Inc. 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c 2025-01-01 Warnings Exact identifier application number: M022 Prevention Mouth Sore Rinse HYDROGEN PEROXIDE Prevention Health Sciences, Inc. 2eae61e4-1800-5fa6-e063-6394a90a9583 2025-01-01 Warnings Exact identifier application number: M022 Antiseptic Lil Drug Store Products EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Lil' Drug Store Products, Inc dca36a30-2c9f-4d0b-be88-b45c7046f509 2024-12-31 Warnings Exact identifier application number: M022 Sensodyne Clinical White Intensive Clean POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC f193ec40-032f-42c7-81f1-029ec8989374 2024-12-31 Warnings Exact identifier application number: M022 TeethWhitening Kit TEETHWHITENING KIT Jiangxi Dentalbright Technology Co., Ltd. 29393313-217a-dc3a-e063-6294a90addb1 2024-12-20 Warnings Exact identifier application number: M022 Breezers Cool Berry PECTIN Mondelez Global LLC b31d0078-21d7-4d18-a8d3-7c8d48d6d004 2024-12-20 Warnings Exact identifier application number: M022 Breezers Creamy Strawberry PECTIN Mondelez Global LLC 777fd6db-f129-4489-8312-4b1aca94878e 2024-12-20 Warnings Exact identifier application number: M022 Halls Breezers Sugar Free Cool Berry PECTIN Mondelez Global LLC dd1b4b17-4f73-4052-9589-d5fd6bb059bb 2024-12-20 Warnings Exact identifier application number: M022 Oral Gel Oral Pain Relief BENZOCAINE BENZALKONIUM CHLORIDE Savvy Care and Cosmetics 05ede7e4-5a0a-c942-e063-6294a90a8a24 2024-12-19 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint SODIUM BICARBONATE Lotus Brands, Inc. 4a95c8c1-db7c-4791-ac58-3eac216a0126 2024-12-18 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon SODIUM BICARBONATE Lotus Brands, Inc. 6703b29d-cdc9-4c74-91c0-fb0c98dd043e 2024-12-18 Warnings Exact identifier application number: M022 Red Cross Oral Pain Relief BENZOCAINE The Mentholatum Company cbd41429-f730-4577-9f06-ef1831cf62e1 2024-12-17 Warnings Exact identifier application number: M022 Red Cross Canker Sore BENZOCAINE The Mentholatum Company 54cfff96-6665-4b36-a15d-10bf6cf3a1f9 2024-12-17 Warnings Exact identifier application number: M022 Benzoin Tincture BENZOIN RESIN 116956644 2981217f-f250-c090-e063-6294a90a85b0 2024-12-17 Warnings Exact identifier application number: M022 Kank-A Mouth Pain BENZOCAINE Blistex Inc. eebc03ba-f849-4e70-a653-834f383b6aa4 2024-12-17 Warnings Exact identifier application number: M022
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0316-69 00363031669 1 TUBE in 1 CARTON (0363-0316-69) / 9 g in 1 TUBE 1 tube 2022-06-22 0000-00-00 No No Current