FDA.reportPublic FDA data

CEPASTAT

Product NDC
63736-205
11-digit product format
637360205
Labeler code
63736
Product ID
63736-205_c763b32e-91b7-4c97-baf5-f523f385a96e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Dextromethorphan HBr, Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Insight Pharmaceuticals LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-10-01
Marketing end
0000-00-00
Substance
MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
10 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63736-205DDiscontinued by firm2026-10-05
excluded packagepackage63736-20563736-205-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-205-01CEPASTATSore throat and Cough6 in 1 BLISTER PACKLOZENGE63
63736-205-01CEPASTATSore throat and Cough3 in 1 CARTONLOZENGE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-205CEPASTAT SORE THROAT AND COUGH (BENZOCAINE, DEXTROMETHORPHAN HBR, MENTHOL) LOZENGE [INSIGHT PHARMACEUTICALS LLC]3Legacy NDC, 2 package rows20241105_93f0e60f-4dda-4ec9-b391-e059a0876654.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045532benzocaine 6 MG / dextromethorphan HBr 5 MG / menthol 10 MG Oral LozengePSN93f0e60f-4dda-4ec9-b391-e059a08766543
1872897CEPASTAT Sore Throat & Cough 6 MG / 5 MG / 10 MG Oral LozengePSN93f0e60f-4dda-4ec9-b391-e059a08766543
1872897benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral Lozenge [Cepastat Sore Throat & Cough]SBD93f0e60f-4dda-4ec9-b391-e059a08766543
1045532benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral LozengeSCD93f0e60f-4dda-4ec9-b391-e059a08766543
1872897Cepastat Sore Throat & Cough (benzocaine 6 MG / dextromethorphan HBr 5 MG / menthol 10 MG) Oral LozengeSY93f0e60f-4dda-4ec9-b391-e059a08766543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-205-01637360205013 BLISTER PACK in 1 CARTON (63736-205-01) > 6 LOZENGE in 1 BLISTER PACK3 blister pack2016-10-010000-00-00NoNoCurrent