NDC 53809-206

DOMETUSS-DA

Chlorpheniramine Maleate, Phenylephrine Hydrochloride

DOMETUSS-DA is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Domel Laboratories. The primary component is Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

• Product ID: 53809-206_0a1b6678-feef-4381-ad56-c5023e5c7f79
• NDC: 53809-206
• Product Type: Human Otc Drug
• Proprietary Name: DOMETUSS-DA
• Generic Name: Chlorpheniramine Maleate, Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2016-01-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Domel Laboratories
• Substance Name: CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/5mL; mg/5mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 53809-206-04

118 mL in 1 BOTTLE (53809-206-04)

• Marketing Start Date: 2016-01-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53809-206-04 [53809020604]

DOMETUSS-DA LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-01-21

Drug Details

Active Ingredients

Ingredient	Strength
CHLORPHENIRAMINE MALEATE	1 mg/5mL

OpenFDA Data

• SPL SET ID: b5def3fb-90b9-4b7e-bb22-745804b0566a
• Manufacturer:
  • Domel Laboratories
• UNII:
  • V1Q0O9OJ9Z
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1429345

NDC Crossover Matching brand name "DOMETUSS-DA" or generic name "Chlorpheniramine Maleate, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
53809-206	DOMETUSS-DA	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
63102-115	ACTIDOM DA	Chlorpheniramine maleate, Phenylephrine hydrochloride