Home NDC 0363-5334 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 Ingredient Strength BENZOCAINE 200 mg/mL
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 308657 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-5334-00 Walgreens Mouth Sore Relief 1 in 1 BLISTER PACK LIQUID 1 4 0363-5334-00 Walgreens Mouth Sore Relief 14.7 mL in 1 BOTTLE LIQUID 14.7 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-5334 WALGREENS MOUTH SORE RELIEF (BENZOCAINE) LIQUID [WALGREENS] 3 Current NDC, 2 package rows 20250124_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 9 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0363-5334-00 00363533400 1 BOTTLE in 1 BLISTER PACK (0363-5334-00) / 14.7 mL in 1 BOTTLE 1 bottle 2024-12-01 No No Current