Home NDC 0280-0088 Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz
Product NDC 0280-0088
11-digit product format 002800088
Labeler code 0280
Product ID 0280-0088_45265106-f83e-e8a2-e063-6294a90a475c
Type HUMAN OTC DRUG
Nonproprietary name chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-05
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 250; 10; 2; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1536477 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-0088-01 Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz 2 in 1 POUCH TABLET, EFFERVESCENT 2 13 0280-0088-01 Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz 20 in 1 CARTON TABLET, EFFERVESCENT 20 13 0280-0088-02 Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz 12 in 1 CARTON TABLET, EFFERVESCENT 12 13 0280-0088-02 Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz 2 in 1 POUCH TABLET, EFFERVESCENT 2 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0088 ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] 12 Current NDC, Legacy NDC, 4 package rows 20240816_a2f0285b-8550-fd26-e053-2995a90ab615.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0088-01 00280008801 20 POUCH in 1 CARTON (0280-0088-01) / 2 TABLET, EFFERVESCENT in 1 POUCH 20 pouch 2022-04-05 0000-00-00 No No Current 0280-0088-02 00280008802 12 POUCH in 1 CARTON (0280-0088-02) / 2 TABLET, EFFERVESCENT in 1 POUCH 12 pouch 2023-03-08 No No Current