NDC 0536-1045

Sore Throat and Cough

Benzocaine And Dextromethorphan Hydrobromide

Sore Throat and Cough is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Benzocaine; Dextromethorphan Hydrobromide.

• Product ID: 0536-1045_54fcd3ed-3334-4231-9d0e-ef623b4da257
• NDC: 0536-1045
• Product Type: Human Otc Drug
• Proprietary Name: Sore Throat and Cough
• Generic Name: Benzocaine And Dextromethorphan Hydrobromide
• Dosage Form: Lozenge
• Route of Administration: ORAL
• Marketing Start Date: 2014-11-04
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Rugby Laboratories
• Substance Name: BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 8 mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 0536-1045-21

1 BLISTER PACK in 1 CARTON (0536-1045-21) > 18 LOZENGE in 1 BLISTER PACK

• Marketing Start Date: 2014-11-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0536-1045-21 [00536104521]

Sore Throat and Cough LOZENGE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-11-04
• Marketing End Date: 2017-06-30

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	7.5 mg/1

OpenFDA Data

• SPL SET ID: aeb7f1b6-edf1-45b7-9bc8-903b3b29b52d
• Manufacturer:
  • Rugby Laboratories
• UNII:
  • U3RSY48JW5
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1039251

NDC Crossover Matching brand name "Sore Throat and Cough" or generic name "Benzocaine And Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
0536-1045	Sore Throat and Cough	benzocaine and dextromethorphan hydrobromide
63824-741	Cepacol	Benzocaine and Dextromethorphan Hydrobromide
63824-742	Cepacol	Benzocaine and Dextromethorphan Hydrobromide
63824-743	Cepacol	BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
63824-744	Cepacol	BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
37000-998	Vicks Formula 44	Benzocaine and Dextromethorphan hydrobromide