NDC 63162-508

Balamine DM Syrup

Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

Balamine DM Syrup is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Ballay Pharmaceuticals, Inc.. The primary component is Chlorpheniramine Maleate; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

• Product ID: 63162-508_34f2008d-8ed5-4ef7-8c03-c8fd56d77d93
• NDC: 63162-508
• Product Type: Human Otc Drug
• Proprietary Name: Balamine DM Syrup
• Generic Name: Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2013-04-23
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Ballay Pharmaceuticals, Inc.
• Substance Name: CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 2 mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 63162-508-20

6 BOTTLE in 1 TRAY (63162-508-20) > 20 mL in 1 BOTTLE

• Marketing Start Date: 2013-04-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63162-508-16 [63162050816]

Balamine DM Syrup LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-04-23
• Inactivation Date: 2019-11-27

NDC 63162-508-20 [63162050820]

Balamine DM Syrup LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-12-30
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
CHLORPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

• SPL SET ID: 9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae5
• Manufacturer:
  • Ballay Pharmaceuticals, Inc.
• UNII:
  • V1Q0O9OJ9Z
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1363752

NDC Crossover Matching brand name "Balamine DM Syrup" or generic name "Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
63162-508	Balamine	Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
49963-118	Bronkids	Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide