Home NDC 0280-8279 ALKA SELTZER COLD Cold and Cough Fast
Product NDC 0280-8279
11-digit product format 002808279
Labeler code 0280
Product ID 0280-8279_5241b11a-72c7-5e67-e063-6394a90a4353
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 5; 162.5 mg/1; mg/1
Pharmacologic classes 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 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 Cough Fast
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/1 ACETAMINOPHEN 162.5 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 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2678223 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 0280-8279-24 00280827924 3 BLISTER PACK in 1 CARTON (0280-8279-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2026-06-01 No No Current