Home NDC 0280-0507 Alka-Seltzer Plus Severe Sinus Cold and Cough
Product NDC 0280-0507
11-digit product format 002800507
Labeler code 0280
Product ID 0280-0507_452662db-192f-a610-e063-6394a90a4a10
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bayer HealthCare LLC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-01-28
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 250; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], 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 Severe Sinus Cold and Cough
Brand name suffix Liquid Gels
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 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 1432488 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 0280-0507-20 Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 8 0280-0507-20 Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels 20 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 20 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0507 ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.] 7 Current NDC, Legacy NDC, 2 package rows 20231205_0dba1329-5b0d-5688-e054-00144ff8d46c.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 9 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Kids Pain and Fever ACETAMINOPHEN CalmCo LLC 5534a784-a7b1-5599-e063-6294a90a7961 2026-06-27 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Select Consumer Group LLC 529d3a51-a248-7c02-e063-6294a90a10ae 2026-06-27 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sportpharm LLC 830ffcaa-7ff8-4732-bc84-6a8c5e78722d 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Strategic Sourcing Services LLC ea2ef485-429e-4c63-ba7b-0a6b32892ad2 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Chain Drug Marketing Association, Inc. 055d8420-c189-4a9e-acdc-21627935c8eb 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Topco Associates, LLC 5f32cf74-dbea-496c-ba23-2040ea354f40 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Salado Sales, Inc. cf3139a5-e36e-48e3-bb6c-e102b0cec555 2026-06-25 Warnings Exact identifier application number: M013 Pain Relief Aspirin ASPIRIN Rite Aid Corporation bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 2026-06-25 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN Walgreen Company 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef 2026-06-25 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Neo-Lubrina Children ACETAMINOPHEN OPMX LLC 5476f4cf-4a5d-2287-e063-6394a90a5ed5 2026-06-17 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 Warnings Exact identifier application number: M013
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 0280-0507-20 00280050720 2 BLISTER PACK in 1 CARTON (0280-0507-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2015-01-28 0000-00-00 No No Current