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 3 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join aspirin chewable, low dose ASPIRIN United Natural Foods, Inc. dba UNFI 6a6ac7fe-91a4-4b55-979a-b53b51505d8b 2026-08-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sam's West Inc 1098d0e7-8202-4018-a2d2-b0c80ee58b56 2026-08-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Safeway, Inc. 5e77dca4-2ff8-4a8c-94bd-f224b680ca23 2026-08-19 Warnings Exact identifier application number: M013 dg health pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Dolgencorp Inc 4d1eddf0-eff7-4c47-b312-30dee08d9e5f 2026-08-19 Warnings Exact identifier application number: M013 Headache Formula Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE ARMY AND AIR FORCE EXCHANGE SERVICE ee8d0961-7572-471f-8c96-b4c0bd354de2 2026-08-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Rugby Laboratories 76f10ee2-1d6a-097c-e053-2991aa0af526 2026-08-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Major Pharmaceuticals 780aad35-d0f1-44b1-e053-2991aa0af9a7 2026-08-18 Warnings Exact identifier application number: M013 CHILDRENS PAIN AND FEVER ACETAMINOPHEN Amazon.com Services LLC 5eacbc4f-d20a-4c22-9680-4a648e24de43 2026-08-18 Warnings Exact identifier application number: M013 Pain Relief Childrens ACETAMINOPHEN WinCo Foods, LLC 15921c3f-e8d4-4794-983f-63bb926f6f86 2026-08-15 Warnings Exact identifier application number: M013 Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY e4cbfb06-d826-4d08-95d6-60305c417625 2026-08-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN CVS Pharmacy,Inc. 3738d35c-1e83-40df-9292-c54e6b2c8353 2026-08-14 Warnings Exact identifier application number: M013 CVS Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY 22a48a33-995b-481e-9e4e-1ad7ec346f44 2026-08-14 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN AND CAFFEINE CVS Pharmacy 31ccc867-ca83-70a9-f3d5-5644030047b8 2026-08-13 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Topco Associates, LLC 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101 2026-08-12 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN HARRIS TEETER 54e69d5a-55d7-4ebe-8494-0be93613f1e2 2026-08-12 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN HARRIS TEETER c6a28c83-60c9-3304-e053-2a95a90aa06c 2026-08-12 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN HARRIS TEETER 93cbd3cb-1072-89e6-e053-2995a90a2f15 2026-08-12 Warnings Exact identifier application number: M013 Adult Chewable Aspirin ASPIRIN HARRIS TEETER c6a28617-1769-7a7d-e053-2995a90a1ea0 2026-08-12 Warnings Exact identifier application number: M013 Gencare- Pain Relief Acetaminophen ACETAMINOPHEN Pioneer Life Sciences, LLC 2111c91b-2fd7-4ab3-946a-d4e0cf46399a 2026-08-12 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Salado Sales, Inc. 1dbd8480-5cb4-4577-9091-b2a2add4f1af 2026-08-12 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