Package 85454-0421-1

Brand: onral oral pain reliever mouthwash

Generic: benzocaine
NDC Package

Package Facts

Identity

Package NDC 85454-0421-1
Digits Only 8545404211
Product NDC 85454-0421
Description

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

Marketing

Marketing Status
Marketed Since 2025-07-01
Brand onral oral pain reliever mouthwash
Generic benzocaine
Sample Package No

Linked Drug Pages (1)

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"}