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
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
10; 200 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quality Choice Oral Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE10 mg/g
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, U3RSY48JW5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-035-12Quality Choice Oral Pain Relief1 in 1 CARTONGEL11
83324-035-12Quality Choice Oral Pain Relief11.9 g in 1 TUBEGEL11.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-035QUALITY CHOICE ORAL PAIN RELIEF (BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%) GEL [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1Current NDC, 2 package rows20240417_162702b4-4bf7-8868-e063-6294a90a5921.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-035-12833240035121 TUBE in 1 CARTON (83324-035-12) / 11.9 g in 1 TUBE1 tube2024-04-01NoNoHistorical