NDC 63736-205

CEPASTAT Sore throat and Cough

Benzocaine, Dextromethorphan Hbr, Menthol

CEPASTAT Sore throat and Cough is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Insight Pharmaceuticals Llc. The primary component is Menthol; Benzocaine; Dextromethorphan Hydrobromide.

• Product ID: 63736-205_c763b32e-91b7-4c97-baf5-f523f385a96e
• NDC: 63736-205
• Product Type: Human Otc Drug
• Proprietary Name: CEPASTAT Sore throat and Cough
• Generic Name: Benzocaine, Dextromethorphan Hbr, Menthol
• Dosage Form: Lozenge
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Insight Pharmaceuticals LLC
• Substance Name: MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 10 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63736-205-01

3 BLISTER PACK in 1 CARTON (63736-205-01) > 6 LOZENGE in 1 BLISTER PACK

• Marketing Start Date: 2016-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63736-205-01 [63736020501]

CEPASTAT Sore throat and Cough LOZENGE

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-01

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	10 mg/1

OpenFDA Data

• SPL SET ID: 93f0e60f-4dda-4ec9-b391-e059a0876654
• Manufacturer:
  • Insight Pharmaceuticals LLC
• UNII:
  • L7T10EIP3A
  • 9D2RTI9KYH
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 1045532
  • 1872897