Home NDC 0280-8265 Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve
Product NDC 0280-8265
11-digit product format 002808265
Labeler code 0280
Product ID 0280-8265_4f0c1b8e-3fb0-ccf2-e063-6394a90acd15
Type HUMAN OTC DRUG
Nonproprietary name aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-01
Substance ASPIRIN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE
Active strength 325; 2; 10; 7.8 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [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 2027-12-31
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 Cold Cold and Congestion Severe Night Fast Dissolve
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 325 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE BITARTRATE 7.8 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 1537029 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0280-8265-16 00280826516 8 POUCH in 1 CARTON (0280-8265-16) / 2 TABLET, EFFERVESCENT in 1 POUCH 8 pouch 2026-06-01 No No Current 0280-8265-24 00280826524 12 POUCH in 1 CARTON (0280-8265-24) / 2 TABLET, EFFERVESCENT in 1 POUCH 12 pouch 2026-06-01 No No Current