NDC 0280-0922

Alka-Seltzer Plus Night Severe Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride

Alka-Seltzer Plus Night Severe Cold and Flu is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 0280-0922_75861e45-da39-3547-e053-2a91aa0af71f
• NDC: 0280-0922
• Product Type: Human Otc Drug
• Proprietary Name: Alka-Seltzer Plus Night Severe Cold and Flu
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-17
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Bayer HealthCare LLC.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0280-0922-06

6 PACKET in 1 CARTON (0280-0922-06) > 1 POWDER, FOR SOLUTION in 1 PACKET

• Marketing Start Date: 2014-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0280-0922-06 [00280092206]

Alka-Seltzer Plus Night Severe Cold and Flu POWDER, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-17

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/1

OpenFDA Data

• SPL SET ID: f4c60ca1-ba59-4a92-84a5-6ba65faa56ab
• Manufacturer:
  • Bayer HealthCare LLC.
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1534835
• UPC Code:
  • 0016500559399

NDC Crossover Matching brand name "Alka-Seltzer Plus Night Severe Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0280-0922	Alka-Seltzer Plus Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
36800-848	Cold and Flu Severe Nighttime	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
63824-593	Mucinex Fast-Max	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride
0363-6140	NightTime Cold	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
37000-530	NyQuil Severe plus	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
69423-989	NyQuil VapoCOOL SEVERE	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
0363-0114	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
0363-8997	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
36800-659	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
49035-624	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
49035-669	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
68210-4087	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
37000-528	Sinex Severe plus	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
64336-175	Sinex Severe plus	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
50580-571	TYLENOL COLD MAX	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
50580-369	Tylenol Cold plus Flu plus Cough	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
37000-531	Vicks Formula 44 VapoCool	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
37000-812	Vicks NyQuil	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
37000-815	Vicks NyQuil	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
0363-6111	Walgreen Nighttime Cold and Flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride