Home NDC 0280-0055 Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz
Product NDC 0280-0055
11-digit product format 002800055
Labeler code 0280
Product ID 0280-0055_45261b62-142d-8c69-e063-6294a90a011f
Type HUMAN OTC DRUG
Nonproprietary name chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-15
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 2; 5; 10; 325 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 Maximum Strength Sinus Congestion and Pain PowerFast Fizz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 ACETAMINOPHEN 325 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 2557336 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 0280-0055-01 Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz 10 in 1 CARTON TABLET, EFFERVESCENT 10 6 0280-0055-01 Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz 2 in 1 POUCH TABLET, EFFERVESCENT 2 6 0280-0055-02 Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz 12 in 1 CARTON TABLET, EFFERVESCENT 12 6 0280-0055-02 Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz 2 in 1 POUCH TABLET, EFFERVESCENT 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0055 ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS CONGESTION AND PAIN POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] 5 Current NDC, Legacy NDC, 4 package rows 20241208_bd97e91f-1ae1-379c-e053-2995a90acfdd.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 0280-0055-01 00280005501 10 POUCH in 1 CARTON (0280-0055-01) / 2 TABLET, EFFERVESCENT in 1 POUCH 10 pouch 2021-06-15 0000-00-00 No No Current 0280-0055-02 00280005502 12 POUCH in 1 CARTON (0280-0055-02) / 2 TABLET, EFFERVESCENT in 1 POUCH 12 pouch 2023-03-08 No No Current