onral oral pain reliever mouthwash

Generic: benzocaine

Labeler: syka pharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name onral oral pain reliever mouthwash
Generic Name benzocaine
Labeler syka pharma inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

benzocaine 50 mg/mL

Manufacturer
Syka Pharma Inc.

Identifiers & Regulatory

Product NDC 85454-0421
Product ID 85454-0421_36b1704e-640d-bab5-e063-6394a90a4145
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 854540421
Hyphenated Format 85454-0421

Supplemental Identifiers

RxCUI
2717653
UPC
0628942758683
UNII
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 onral oral pain reliever mouthwash (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (85454-0421-1) / 230 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

85454-0421-1 1 BOTTLE, PLASTIC in 1 CARTON (85454-0421-1) / 230 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

benzocaine (50 mg/mL)

Linked Drug Pages (1)

Onral Oral Pain Reliever Mouthwash ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36b1704e-640d-bab5-e063-6394a90a4145", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0628942758683"], "unii": ["U3RSY48JW5"], "rxcui": ["2717653"], "spl_set_id": ["5dd8d933-6f32-4eaf-8eca-9365d7de55a2"], "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": ["Syka Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (85454-0421-1)  / 230 mL in 1 BOTTLE, PLASTIC", "package_ndc": "85454-0421-1", "marketing_start_date": "20250701"}], "brand_name": "Onral Oral Pain Reliever Mouthwash", "product_id": "85454-0421_36b1704e-640d-bab5-e063-6394a90a4145", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "85454-0421", "generic_name": "BENZOCAINE", "labeler_name": "Syka Pharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Onral Oral Pain Reliever Mouthwash", "active_ingredients": [{"name": "BENZOCAINE", "strength": "50 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}