cepastat sore throat and cough

Generic: benzocaine, dextromethorphan hbr, menthol

Labeler: insight pharmaceuticals llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cepastat sore throat and cough
Generic Name benzocaine, dextromethorphan hbr, menthol
Labeler insight pharmaceuticals llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

benzocaine 6 mg/1, dextromethorphan hydrobromide 5 mg/1, menthol 10 mg/1

Manufacturer
Insight Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 63736-205
Product ID 63736-205_1848b27b-f672-42fa-92dd-69f7a776ae63
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2016-10-01

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 63736205
Hyphenated Format 63736-205

Supplemental Identifiers

RxCUI
1045532 1872897
UNII
U3RSY48JW5 9D2RTI9KYH 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 cepastat sore throat and cough (source: ndc)
Generic Name benzocaine, dextromethorphan hbr, menthol (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
  • 5 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (63736-205-01) / 6 LOZENGE in 1 BLISTER PACK
source: ndc

Packages (1)

63736-205-01 3 BLISTER PACK in 1 CARTON (63736-205-01) / 6 LOZENGE in 1 BLISTER PACK

Ingredients (3)

benzocaine (6 mg/1) dextromethorphan hydrobromide (5 mg/1) menthol (10 mg/1)

Linked Drug Pages (1)

CEPASTAT Sore throat and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1848b27b-f672-42fa-92dd-69f7a776ae63", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "9D2RTI9KYH", "L7T10EIP3A"], "rxcui": ["1045532", "1872897"], "spl_set_id": ["93f0e60f-4dda-4ec9-b391-e059a0876654"], "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": ["Insight Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (63736-205-01)  / 6 LOZENGE in 1 BLISTER PACK", "package_ndc": "63736-205-01", "marketing_start_date": "20161001"}], "brand_name": "CEPASTAT Sore throat and Cough", "product_id": "63736-205_1848b27b-f672-42fa-92dd-69f7a776ae63", "dosage_form": "LOZENGE", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Standardized Chemical Allergen [EPC]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "63736-205", "generic_name": "Benzocaine, Dextromethorphan HBr, Menthol", "labeler_name": "Insight Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CEPASTAT", "brand_name_suffix": "Sore throat and Cough", "active_ingredients": [{"name": "BENZOCAINE", "strength": "6 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/1"}, {"name": "MENTHOL", "strength": "10 mg/1"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20161001", "listing_expiration_date": "20261231"}