cepacol extra strength sore throat cherry

Generic: benzocaine and menthol

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 cherry
Generic Name benzocaine and menthol
Labeler rb health (us) llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

benzocaine 15 mg/1, menthol, unspecified form 3.6 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-713
Product ID 63824-713_31582713-bc53-d453-e063-6394a90a19e6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2013-07-15

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 63824713
Hyphenated Format 63824-713

Supplemental Identifiers

RxCUI
824574 1235477
UPC
0363824710167
UNII
U3RSY48JW5 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 cepacol extra strength sore throat cherry (source: ndc)
Generic Name benzocaine and menthol (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
  • 3.6 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (63824-713-16) / 8 LOZENGE in 1 BLISTER PACK
source: ndc

Packages (1)

63824-713-16 2 BLISTER PACK in 1 CARTON (63824-713-16) / 8 LOZENGE in 1 BLISTER PACK

Ingredients (2)

benzocaine (15 mg/1) menthol, unspecified form (3.6 mg/1)

Linked Drug Pages (1)

Cepacol Extra Strength Sore Throat cherry ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31582713-bc53-d453-e063-6394a90a19e6", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0363824710167"], "unii": ["U3RSY48JW5", "L7T10EIP3A"], "rxcui": ["824574", "1235477"], "spl_set_id": ["941e36dd-d8d0-4e5c-8585-10e8f06bf8f0"], "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 (63824-713-16)  / 8 LOZENGE in 1 BLISTER PACK", "package_ndc": "63824-713-16", "marketing_start_date": "20130715"}], "brand_name": "Cepacol Extra Strength Sore Throat cherry", "product_id": "63824-713_31582713-bc53-d453-e063-6394a90a19e6", "dosage_form": "LOZENGE", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "63824-713", "generic_name": "Benzocaine and Menthol", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cepacol", "brand_name_suffix": "Extra Strength Sore Throat cherry", "active_ingredients": [{"name": "BENZOCAINE", "strength": "15 mg/1"}, {"name": "MENTHOL, UNSPECIFIED FORM", "strength": "3.6 mg/1"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130715", "listing_expiration_date": "20261231"}