Home NDC 83324-035 Quality Choice Oral Pain Relief
Product NDC 83324-035
11-digit product format 833240035
Labeler code 83324
Product ID 83324-035_16271ed7-9c13-93e0-e063-6294a90a1adc
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine 20%, Benzalkonium Chloride 1%
Dosage form GEL
Route TOPICAL
Labeler Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
Substance BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength 200; 10 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Quality Choice Oral Pain Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g BENZALKONIUM CHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup F5UM2KM3W7 Internal UNII 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 83324-035-12 Quality Choice Oral Pain Relief 1 in 1 CARTON GEL 1 1 83324-035-12 Quality Choice Oral Pain Relief 11.9 g in 1 TUBE GEL 11.9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-035 QUALITY CHOICE ORAL PAIN RELIEF (BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%) GEL [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 Current NDC, 2 package rows 20240417_162702b4-4bf7-8868-e063-6294a90a5921.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 32 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83324-035-12 83324003512 1 TUBE in 1 CARTON (83324-035-12) / 11.9 g in 1 TUBE 1 tube 2024-04-01 No No Current