Home NDC 0280-0089 Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz
Product NDC 0280-0089
11-digit product format 002800089
Labeler code 0280
Product ID 0280-0089_4526573a-7900-980c-e063-6394a90a5fbd
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, guaifenesin
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Bayer Healthcare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-05
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 200 mg/1; mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Cough Chest Congestion PowerFast Fizz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2598125 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 0280-0089-01 Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz 2 in 1 POUCH TABLET, EFFERVESCENT 2 12 0280-0089-01 Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz 20 in 1 CARTON TABLET, EFFERVESCENT 20 12 0280-0089-02 Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz 2 in 1 POUCH TABLET, EFFERVESCENT 2 12 0280-0089-02 Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz 12 in 1 CARTON TABLET, EFFERVESCENT 12 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0089 ALKA SELTZER PLUS MAXIMUM STRENGTH COUGH CHEST CONGESTION POWERFAST FIZZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] 11 Current NDC, Legacy NDC, 4 package rows 20241208_a32e2a5e-9aa0-4e7c-e053-2995a90a3190.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 98 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 0280-0089-01 00280008901 20 POUCH in 1 CARTON (0280-0089-01) / 2 TABLET, EFFERVESCENT in 1 POUCH 20 pouch 2022-04-05 0000-00-00 No No Current 0280-0089-02 00280008902 12 POUCH in 1 CARTON (0280-0089-02) / 2 TABLET, EFFERVESCENT in 1 POUCH 12 pouch 2023-03-08 No No Current