NDC 63824-744

Cepacol Extra Strength Sore Throat and Cough

Benzocaine And Dextromethorphan Hydrobromide

Cepacol Extra Strength Sore Throat and Cough is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Rb Health (us) Llc. The primary component is Benzocaine; Dextromethorphan Hydrobromide.

• Product ID: 63824-744_1da0b913-07c4-47f4-b5ca-ce79b713d7d9
• NDC: 63824-744
• Product Type: Human Otc Drug
• Proprietary Name: Cepacol Extra Strength Sore Throat and Cough
• Generic Name: Benzocaine And Dextromethorphan Hydrobromide
• Dosage Form: Lozenge
• Route of Administration: ORAL
• Marketing Start Date: 2014-05-05
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: RB Health (US) LLC
• Substance Name: BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 8 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63824-744-16

2 BLISTER PACK in 1 CARTON (63824-744-16) > 8 LOZENGE in 1 BLISTER PACK

• Marketing Start Date: 2014-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63824-744-36 [63824074436]

Cepacol Extra Strength Sore Throat and Cough LOZENGE

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-05-01

NDC 63824-744-94 [63824074494]

Cepacol Extra Strength Sore Throat and Cough LOZENGE

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-05-05

NDC 63824-744-16 [63824074416]

Cepacol Extra Strength 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: 2014-05-05

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	7.5 mg/1

OpenFDA Data

• SPL SET ID: c0cc32db-90f0-4106-8538-89821083ece1
• Manufacturer:
  • RB Health (US) LLC
• UNII:
  • U3RSY48JW5
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1039255
  • 1039251

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

NDC	Brand Name	Generic Name
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
0536-1045	Sore Throat and Cough	benzocaine and dextromethorphan hydrobromide
37000-998	Vicks Formula 44	Benzocaine and Dextromethorphan hydrobromide