Home NDC 0280-8268 ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve
Product NDC 0280-8268
11-digit product format 002808268
Labeler code 0280
Product ID 0280-8268_5088780b-c1e6-4136-e063-6294a90a9caa
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 2026-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 10; 2; 5; 250 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 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 Flu and Congestion Severe Fast Dissolve
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 ACETAMINOPHEN 250 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# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0280-8268-01 00280826801 2 TABLET, EFFERVESCENT in 1 POUCH (0280-8268-01) 2026-06-01 No No Current 0280-8268-16 00280826816 8 POUCH in 1 CARTON (0280-8268-16) / 2 TABLET, EFFERVESCENT in 1 POUCH 8 pouch 2026-06-01 No No Current 0280-8268-24 00280826824 12 POUCH in 1 CARTON (0280-8268-24) / 2 TABLET, EFFERVESCENT in 1 POUCH 12 pouch 2026-06-01 No No Current 0280-8268-48 00280826848 24 POUCH in 1 CARTON (0280-8268-48) / 2 TABLET, EFFERVESCENT in 1 POUCH 24 pouch 2026-06-01 No No Current 0280-8268-72 00280826872 36 POUCH in 1 CARTON (0280-8268-72) / 2 TABLET, EFFERVESCENT in 1 POUCH 36 pouch 2026-06-01 No No Current