oral pain relief

Generic: benzocaine and benzalkonium chloride

Labeler: universal distribution center llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name oral pain relief
Generic Name benzocaine and benzalkonium chloride
Labeler universal distribution center llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .01 g/g, benzocaine .2 g/g

Manufacturer
Universal Distribution Center LLC

Identifiers & Regulatory

Product NDC 52000-060
Product ID 52000-060_28d09e8b-190f-40da-ab8a-9bd2d41ae419
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2024-01-05

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 52000060
Hyphenated Format 52000-060

Supplemental Identifiers

RxCUI
1595155
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 oral pain relief (source: ndc)
Generic Name benzocaine and benzalkonium chloride (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .01 g/g
  • .2 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (52000-060-02) / 14 g in 1 TUBE
source: ndc

Packages (1)

52000-060-02 1 TUBE in 1 CARTON (52000-060-02) / 14 g in 1 TUBE

Ingredients (2)

benzalkonium chloride (.01 g/g) benzocaine (.2 g/g)

Linked Drug Pages (1)

Oral Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "28d09e8b-190f-40da-ab8a-9bd2d41ae419", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["F5UM2KM3W7", "U3RSY48JW5"], "rxcui": ["1595155"], "spl_set_id": ["18520f9b-4d35-1e9c-e063-6294a90aaa39"], "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": ["Universal Distribution Center LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (52000-060-02)  / 14 g in 1 TUBE", "package_ndc": "52000-060-02", "marketing_start_date": "20240501"}], "brand_name": "Oral Pain Relief", "product_id": "52000-060_28d09e8b-190f-40da-ab8a-9bd2d41ae419", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "52000-060", "generic_name": "Benzocaine and Benzalkonium Chloride", "labeler_name": "Universal Distribution Center LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Oral Pain Relief", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".01 g/g"}, {"name": "BENZOCAINE", "strength": ".2 g/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240105", "listing_expiration_date": "20261231"}