orasep

Generic: benzocaine, menthol, cetylpyridinium chloride

Labeler: llorens pharmaceutical international division
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name orasep
Generic Name benzocaine, menthol, cetylpyridinium chloride
Labeler llorens pharmaceutical international division
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzocaine 2 mg/100mL, cetylpyridinium chloride .1 mg/100mL, menthol .5 mg/100mL

Manufacturer
Llorens Pharmaceutical International Division

Identifiers & Regulatory

Product NDC 54859-504
Product ID 54859-504_47461540-c155-bc33-e063-6394a90aaa9c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2010-04-01

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 54859504
Hyphenated Format 54859-504

Supplemental Identifiers

RxCUI
1426687 1485227
UNII
U3RSY48JW5 D9OM4SK49P L7T10EIP3A
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 orasep (source: ndc)
Generic Name benzocaine, menthol, cetylpyridinium chloride (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/100mL
  • .1 mg/100mL
  • .5 mg/100mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, SPRAY (54859-504-01)
source: ndc

Packages (1)

54859-504-01 30 mL in 1 BOTTLE, SPRAY (54859-504-01)

Ingredients (3)

benzocaine (2 mg/100mL) cetylpyridinium chloride (.1 mg/100mL) menthol (.5 mg/100mL)

Linked Drug Pages (1)

Orasep ndc-match (0.9)

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"}