Home NDC 63824-732 Cepacol
Product NDC 63824-732
11-digit product format 638240732
Labeler code 63824
Product ID 63824-732_51a73861-dad4-e880-e063-6294a90a9190
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine and Menthol
Dosage form LOZENGE
Route ORAL
Labeler Reckitt Benckiser LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-07-15
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength 15; 2.6 mg/1; mg/1
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cepacol
Brand name suffix Extra Strength Sore Throat honey lemon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 15 mg/1 MENTHOL, UNSPECIFIED FORM 2.6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858664 Internal RxNorm lookup 1235472 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63824-732-16 CepacolExtra Strength Sore Throat honey lemon 8 in 1 BLISTER PACK LOZENGE 8 12 63824-732-16 CepacolExtra Strength Sore Throat honey lemon 2 in 1 CARTON LOZENGE 2 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-732 CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RB HEALTH (US) LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250330_d771095b-7de3-48f3-a125-8bc76e7d1778.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 15 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-732-16 63824073216 2 BLISTER PACK in 1 CARTON (63824-732-16) / 8 LOZENGE in 1 BLISTER PACK 2 blister pack 2013-07-15 0000-00-00 No No Current