NDC 52083-650

GENCONTUSS

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

GENCONTUSS is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 52083-650_5d0747f8-3088-4716-896c-f71383c284c2
• NDC: 52083-650
• Product Type: Human Otc Drug
• Proprietary Name: GENCONTUSS
• Generic Name: Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2015-06-08
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: KRAMER NOVIS
• Substance Name: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/5mL; mg/5mL; mg/5mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 52083-650-16

473 mL in 1 BOTTLE, PLASTIC (52083-650-16)

• Marketing Start Date: 2015-06-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-650-16 [52083065016]

GENCONTUSS SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-06-08

Drug Details

Active Ingredients

Ingredient	Strength
CHLORPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

• SPL SET ID: 69d16d25-b09b-430e-8e01-0962d840dc21
• Manufacturer:
  • KRAMER NOVIS
• UNII:
  • V1Q0O9OJ9Z
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1363752
• UPC Code:
  • 0352083650161

NDC Crossover Matching brand name "GENCONTUSS" or generic name "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
52083-650	GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
45737-250	BIO-RYTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
49963-532	Bronkids	Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
58552-138	Giltuss Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
58552-139	Giltuss Childrens Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
76117-001	Rycontuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE