NDC 50991-492

Polytussin DM

Dexchlorpheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl

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

• Product ID: 50991-492_5f006df2-adba-3a60-e053-2a91aa0ab206
• NDC: 50991-492
• Product Type: Human Otc Drug
• Proprietary Name: Polytussin DM
• Generic Name: Dexchlorpheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2017-11-22
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Poly Pharmaceuticals, Inc.
• Substance Name: DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50991-492-15

15 mL in 1 BOTTLE (50991-492-15)

• Marketing Start Date: 2017-11-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50991-492-15 [50991049215]

Polytussin DM SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-11-22

NDC 50991-492-16 [50991049216]

Polytussin DM SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-22

Drug Details

Active Ingredients

Ingredient	Strength
DEXCHLORPHENIRAMINE MALEATE	1 mg/5mL

OpenFDA Data

• SPL SET ID: 5f006df2-adb9-3a60-e053-2a91aa0ab206
• Manufacturer:
  • Poly Pharmaceuticals, Inc.
• UNII:
  • 04JA59TNSJ
  • B10YD955QW
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1990881
• UPC Code:
  • 0350991492163

Medicade Reported Pricing

50991049216 POLYTUSSIN DM SYRUP

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Polytussin DM" or generic name "Dexchlorpheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
50991-121	Polytussin DM	Dexbrompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
50991-492	Polytussin DM	DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
69367-334	WesTussin DM	dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl