quality choice oral pain relief

Generic: benzocaine 20%, benzalkonium chloride 1%

Labeler: quality choice (chain drug marketing association)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name quality choice oral pain relief
Generic Name benzocaine 20%, benzalkonium chloride 1%
Labeler quality choice (chain drug marketing association)
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 10 mg/g, benzocaine 200 mg/g

Manufacturer
Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)

Identifiers & Regulatory

Product NDC 83324-035
Product ID 83324-035_16271ed7-9c13-93e0-e063-6294a90a1adc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83324035
Hyphenated Format 83324-035

Supplemental Identifiers

UNII
F5UM2KM3W7 U3RSY48JW5
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name quality choice oral pain relief (source: ndc)
Generic Name benzocaine 20%, benzalkonium chloride 1% (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
  • 200 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (83324-035-12) / 11.9 g in 1 TUBE
source: ndc

Packages (1)

Ingredients (2)

benzalkonium chloride (10 mg/g) benzocaine (200 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "16271ed7-9c13-93e0-e063-6294a90a1adc", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["F5UM2KM3W7", "U3RSY48JW5"], "spl_set_id": ["162702b4-4bf7-8868-e063-6294a90a5921"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (83324-035-12)  / 11.9 g in 1 TUBE", "package_ndc": "83324-035-12", "marketing_start_date": "20240401"}], "brand_name": "Quality Choice Oral Pain Relief", "product_id": "83324-035_16271ed7-9c13-93e0-e063-6294a90a1adc", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "83324-035", "generic_name": "Benzocaine 20%, Benzalkonium Chloride 1%", "labeler_name": "Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Quality Choice Oral Pain Relief", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "10 mg/g"}, {"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}