0280-0022 NDC - ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ ()

Drug Information

  • Product NDC: 0280-0022
  • Proprietary Name: Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz
  • Non Proprietary Name:
  • Active Ingredient(s): 250 mg/1 ACETAMINOPHEN; 2 mg/1 CHLORPHENIRAMINE MALEATE; 10 mg/1 DEXTROMETHORPHAN HYDROBROMIDE; 5 mg/1 PHENYLEPHRINE HYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: Bayer HealthCare LLC.
Product Type:
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:4/1/2020
End Marketing Date:4/5/2022

Package Information

No. Package Code Package Description Billing Unit
10280-0022-0110 POUCH in 1 CARTON (0280-0022-01) / 2 TABLET, EFFERVESCENT in 1 POUCH
20280-0022-0110 POUCH in 1 CARTON (0280-0022-01) / 2 TABLET, EFFERVESCENT in 1 POUCH
30280-0022-0236 POUCH in 1 CARTON (0280-0022-02) / 2 TABLET, EFFERVESCENT in 1 POUCH
40280-0022-0236 POUCH in 1 CARTON (0280-0022-02) / 2 TABLET, EFFERVESCENT in 1 POUCH
50280-0022-033200 BOX in 1 BOX (0280-0022-03) / 1 TABLET, EFFERVESCENT in 1 BOX
60280-0022-033200 BOX in 1 BOX (0280-0022-03) / 1 TABLET, EFFERVESCENT in 1 BOX
70280-0022-0424 POUCH in 1 CARTON (0280-0022-04) / 2 TABLET, EFFERVESCENT in 1 POUCH
80280-0022-0424 POUCH in 1 CARTON (0280-0022-04) / 2 TABLET, EFFERVESCENT in 1 POUCH
90280-0022-0512 POUCH in 1 CARTON (0280-0022-05) / 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC0280-0022The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEAlka-Seltzer Plus Severe Cold and Flu PowerFast FizzThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE4/1/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart341This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBayer HealthCare LLC.Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0280-0022The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEAlka-Seltzer Plus Severe Cold and Flu PowerFast FizzThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE4/1/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM012This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBayer HealthCare LLC.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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