Package 54859-504-01
Brand: orasep
Generic: benzocaine, menthol, cetylpyridinium chloridePackage Facts
Identity
Package NDC
54859-504-01
Digits Only
5485950401
Product NDC
54859-504
Description
30 mL in 1 BOTTLE, SPRAY (54859-504-01)
Marketing
Marketing Status
Brand
orasep
Generic
benzocaine, menthol, cetylpyridinium chloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "47461540-c155-bc33-e063-6394a90aaa9c", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "D9OM4SK49P", "L7T10EIP3A"], "rxcui": ["1426687", "1485227"], "spl_set_id": ["7c50d986-6a7b-425f-90a0-a60e21283bdf"], "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": ["Llorens Pharmaceutical International Division"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, SPRAY (54859-504-01)", "package_ndc": "54859-504-01", "marketing_start_date": "20100401"}], "brand_name": "Orasep", "product_id": "54859-504_47461540-c155-bc33-e063-6394a90aaa9c", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "54859-504", "generic_name": "Benzocaine, Menthol, Cetylpyridinium Chloride", "labeler_name": "Llorens Pharmaceutical International Division", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Orasep", "active_ingredients": [{"name": "BENZOCAINE", "strength": "2 mg/100mL"}, {"name": "CETYLPYRIDINIUM CHLORIDE", "strength": ".1 mg/100mL"}, {"name": "MENTHOL", "strength": ".5 mg/100mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20100401", "listing_expiration_date": "20261231"}