cepacol extra strength sore throat and cough

Generic: benzocaine and dextromethorphan hydrobromide

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cepacol extra strength sore throat and cough
Generic Name benzocaine and dextromethorphan hydrobromide
Labeler rb health (us) llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

benzocaine 7.5 mg/1, dextromethorphan hydrobromide 5 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-744
Product ID 63824-744_30e01214-b6bc-c2bc-e063-6394a90a3180
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-05-05

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 63824744
Hyphenated Format 63824-744

Supplemental Identifiers

RxCUI
1039251 1039255
UPC
0363824740164
UNII
U3RSY48JW5 9D2RTI9KYH
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 cepacol extra strength sore throat and cough (source: ndc)
Generic Name benzocaine and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (63824-744-16) / 8 LOZENGE in 1 BLISTER PACK
source: ndc

Packages (1)

63824-744-16 2 BLISTER PACK in 1 CARTON (63824-744-16) / 8 LOZENGE in 1 BLISTER PACK

Ingredients (2)

benzocaine (7.5 mg/1) dextromethorphan hydrobromide (5 mg/1)

Linked Drug Pages (1)

Cepacol Extra Strength Sore Throat and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30e01214-b6bc-c2bc-e063-6394a90a3180", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0363824740164"], "unii": ["U3RSY48JW5", "9D2RTI9KYH"], "rxcui": ["1039251", "1039255"], "spl_set_id": ["c0cc32db-90f0-4106-8538-89821083ece1"], "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": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-744-16)  / 8 LOZENGE in 1 BLISTER PACK", "package_ndc": "63824-744-16", "marketing_start_date": "20140505"}], "brand_name": "Cepacol Extra Strength Sore Throat and Cough", "product_id": "63824-744_30e01214-b6bc-c2bc-e063-6394a90a3180", "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": "63824-744", "generic_name": "BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cepacol", "brand_name_suffix": "Extra Strength Sore Throat and Cough", "active_ingredients": [{"name": "BENZOCAINE", "strength": "7.5 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140505", "listing_expiration_date": "20261231"}