NDC 0280-1545

Alka-Seltzer Plus Cold Night

Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate

Alka-Seltzer Plus Cold Night is a Oral Tablet, Effervescent in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Aspirin; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Bitartrate.

• Product ID: 0280-1545_7588ea67-68aa-4dc0-e053-2991aa0aa471
• NDC: 0280-1545
• Product Type: Human Otc Drug
• Proprietary Name: Alka-Seltzer Plus Cold Night
• Generic Name: Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate
• Dosage Form: Tablet, Effervescent
• Route of Administration: ORAL
• Marketing Start Date: 2018-09-14
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Bayer HealthCare LLC.
• Substance Name: ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE
• Active Ingredient Strength: 500 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0280-1545-20

10 POUCH in 1 CARTON (0280-1545-20) > 2 TABLET, EFFERVESCENT in 1 POUCH

• Marketing Start Date: 2018-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0280-1545-20 [00280154520]

Alka-Seltzer Plus Cold Night TABLET, EFFERVESCENT

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-09-14

Drug Details

Active Ingredients

Ingredient	Strength
ASPIRIN	500 mg/1

OpenFDA Data

• SPL SET ID: 7588ea67-68a9-4dc0-e053-2991aa0aa471
• Manufacturer:
  • Bayer HealthCare LLC.
• UNII:
  • V9BI9B5YI2
  • 27O3Q5ML57
  • R16CO5Y76E
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1536503
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• UPC Code:
  • 0016500565000
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

NDC Crossover Matching brand name "Alka-Seltzer Plus Cold Night" or generic name "Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate"

NDC	Brand Name	Generic Name
0280-1545	Alka-Seltzer Plus Cold Night	Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate
0280-1541	Alka-Seltzer Plus Multi-Symptom Cold Night	Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate
0280-0021	Alka-Seltzer Plus Severe Cold Powerfast Fizz Night	aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate