Home NDC 84415-044 Benzocaine
Product NDC 84415-044
11-digit product format 844150044
Labeler code 84415
Product ID 84415-044_2bc582da-83f3-1644-e063-6294a90a8968
Type HUMAN OTC DRUG
Nonproprietary name Topical Anesthetic
Dosage form SPRAY
Route DENTAL; PERIODONTAL
Labeler Everpharm LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-15
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 Benzocaine
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 360348 Internal RxNorm 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 84415-044-01 Benzocaine 1 in 1 POUCH SPRAY 1 1 84415-044-01 Benzocaine 25 in 1 PACKAGE SPRAY 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84415-044 BENZOCAINE (TOPICAL ANESTHETIC) SPRAY [EVERPHARM LLC] 1 Current NDC, 2 package rows 20250117_2bc57111-0f15-b237-e063-6294a90a4471.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 27 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 84415-044-01 84415004401 25 POUCH in 1 PACKAGE (84415-044-01) / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR 25 pouch 2025-01-15 No No Current