Home NDC 63824-744 Cepacol
Product NDC 63824-744
11-digit product format 638240744
Labeler code 63824
Product ID 63824-744_51b5d087-def6-54b3-e063-6294a90ac9ad
Type HUMAN OTC DRUG
Nonproprietary name BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form LOZENGE
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-05
Substance DEXTROMETHORPHAN HYDROBROMIDE; BENZOCAINE
Active strength 5; 7.5 mg/1; mg/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/1 BENZOCAINE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1039251 Internal RxNorm lookup 1039255 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 63824-744-16 CepacolExtra Strength Sore Throat and Cough 8 in 1 BLISTER PACK LOZENGE 8 14 63824-744-16 CepacolExtra Strength Sore Throat and Cough 2 in 1 CARTON LOZENGE 2 14 63824-744-36 CepacolExtra Strength Sore Throat and Cough 3 in 1 CARTON LOZENGE 3 14 63824-744-36 CepacolExtra Strength Sore Throat and Cough 12 in 1 BLISTER PACK LOZENGE 12 14 63824-744-94 CepacolExtra Strength Sore Throat and Cough 4 in 1 BLISTER PACK LOZENGE 4 14 63824-744-94 CepacolExtra Strength Sore Throat and Cough 1 in 1 CARTON LOZENGE 1 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-744 CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RB HEALTH (US) LLC] 10 Current NDC, Legacy NDC, 6 package rows 20250323_c0cc32db-90f0-4106-8538-89821083ece1.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 73 of 178 · 3,551 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 63824-744-16 63824074416 2 BLISTER PACK in 1 CARTON (63824-744-16) / 8 LOZENGE in 1 BLISTER PACK 2 blister pack 2014-05-05 0000-00-00 No No Current 63824-744-36 63824074436 3 BLISTER PACK in 1 CARTON (63824-744-36) > 12 LOZENGE in 1 BLISTER PACK 3 blister pack 2019-05-01 0000-00-00 No No Current 63824-744-94 63824074494 1 BLISTER PACK in 1 CARTON (63824-744-94) > 4 LOZENGE in 1 BLISTER PACK 1 blister pack 2014-05-05 0000-00-00 No No Current