Home NDC 0280-1400 Alka-Seltzer Plus Cold Medicine Sparkling Original
Product NDC 0280-1400
11-digit product format 002801400
Labeler code 0280
Product ID 0280-1400_4526711d-1058-262c-e063-6294a90aef61
Type HUMAN OTC DRUG
Nonproprietary name ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-04-10
Substance ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
Active strength 325; 2; 7.8 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Cold Medicine Sparkling Original
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 325 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 PHENYLEPHRINE BITARTRATE 7.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R16CO5Y76E Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup 27O3Q5ML57 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1536840 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 0280-1400-12 Alka-Seltzer Plus Cold Medicine Sparkling Original 2 in 1 POUCH TABLET, EFFERVESCENT 2 9 0280-1400-12 Alka-Seltzer Plus Cold Medicine Sparkling Original 6 in 1 CARTON TABLET, EFFERVESCENT 6 9 0280-1400-20 Alka-Seltzer Plus Cold Medicine Sparkling Original 10 in 1 CARTON TABLET, EFFERVESCENT 10 9 0280-1400-20 Alka-Seltzer Plus Cold Medicine Sparkling Original 2 in 1 POUCH TABLET, EFFERVESCENT 2 9 0280-1400-32 Alka-Seltzer Plus Cold Medicine Sparkling Original 2 in 1 POUCH TABLET, EFFERVESCENT 2 9 0280-1400-32 Alka-Seltzer Plus Cold Medicine Sparkling Original 16 in 1 CARTON TABLET, EFFERVESCENT 16 9 0280-1400-36 Alka-Seltzer Plus Cold Medicine Sparkling Original 18 in 1 CARTON TABLET, EFFERVESCENT 18 9 0280-1400-36 Alka-Seltzer Plus Cold Medicine Sparkling Original 2 in 1 POUCH TABLET, EFFERVESCENT 2 9 0280-1400-48 Alka-Seltzer Plus Cold Medicine Sparkling Original 24 in 1 CARTON TABLET, EFFERVESCENT 24 9 0280-1400-48 Alka-Seltzer Plus Cold Medicine Sparkling Original 2 in 1 POUCH TABLET, EFFERVESCENT 2 9 0280-1400-72 Alka-Seltzer Plus Cold Medicine Sparkling Original 2 in 1 POUCH TABLET, EFFERVESCENT 2 9 0280-1400-72 Alka-Seltzer Plus Cold Medicine Sparkling Original 36 in 1 CARTON TABLET, EFFERVESCENT 36 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 PHENYLEPHRINE BITARTRATE ACTIVE INGREDIENT 27O3Q5ML57 ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 ASPIRIN ACTIVE MOIETY R16CO5Y76E ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 CALCIUM SILICATE INACTIVE INGREDIENT S4255P4G5M ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-1400 ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] 8 Current NDC, Legacy NDC, 12 package rows 20231205_78537dcf-b157-4b67-a8b2-5cb144815166.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 65 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join basic care acetaminophen pm ACETAMINOPHEN, DIPHENHYDRAMINE HCL Amazon.com Services LLC 64a0084a-e29e-4c1a-8704-13a3e1238f76 2024-07-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Walmart Inc. 152c013a-c81c-f8f9-e063-6294a90a9f23 2024-07-15 Warnings Exact identifier application number: M013 Diphenhydramine HCL DIPHENHYDRAMINE HCL NuCare Pharmaceuticals, Inc. 5411544e-3c2d-4e42-e054-00144ff8d46c 2024-07-10 Warnings Exact identifier application number: M013 good sense pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L. Perrigo Company b97c51ad-4953-4491-9ceb-395550eb5296 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 065e6f1b-f68c-491a-a157-84961a07e3d9 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 3b7b6725-2996-44d3-89a3-032384e7e2ce 2024-07-10 Warnings Exact identifier application number: M013 equate pain and fever infants ACETAMINOPHEN Wal-Mart Stores Inc 8a152c8d-8ae0-4201-8bb9-7b22c3577415 2024-07-10 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WinCo Foods, LLC 3c57498c-86b0-4ba3-881e-c742a2e8ece5 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WinCo Foods, LLC c358d1dd-9fcb-4d18-9521-8f898b98a732 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN WinCo Foods, LLC 15430025-f25e-4fe7-b1fe-4eda4684081a 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Easy Tabs Extra Strength ACETAMINOPHEN WinCo Foods, LLC 0631f003-4852-4034-a1c5-1552804b1660 2024-07-09 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Bryant Ranch Prepack 61ecf3c9-42fa-4ae4-bd3b-694090477b9a 2024-07-09 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC fa0ce51f-441d-4409-8617-b3402b00f187 2024-07-08 Warnings Exact identifier application number: M013 Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 81d4e8f5-2f15-462b-be71-ef05f0b791ab 2024-07-05 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 31a97a6a-e5c8-429a-b497-330f0d84777d 2024-07-05 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Meijer Distribution Inc 375b2142-3c89-469c-98fd-bd4b63aeaa11 2024-07-05 Warnings Exact identifier application number: M013 Best Choice Effervescent Pain Reliever 36 ASPIRIN VALU MERCHANDISERS COMPANY 12f1278e-88b6-0460-e063-6394a90abf0e 2024-07-03 Warnings Exact identifier application number: M013 Topcare pain and fever ACETAMINOPHEN Topco Associates LLC 950b16d5-65db-402d-8ec6-eec9e1e174dd 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WALMART INC. 16d5b56f-7e56-0c91-e063-6394a90a4b8e 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALMART INC. 16d5786c-2346-f970-e063-6394a90a0a8c 2024-07-03 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 0280-1400-12 00280140012 2 in 1 POUCH Historical 0280-1400-20 00280140020 10 in 1 CARTON Historical 0280-1400-32 00280140032 16 POUCH in 1 CARTON (0280-1400-32) / 2 TABLET, EFFERVESCENT in 1 POUCH 16 pouch 2008-04-10 0000-00-00 No No Current 0280-1400-36 00280140036 18 in 1 CARTON Historical 0280-1400-48 00280140048 24 in 1 CARTON Historical 0280-1400-72 00280140072 2 in 1 POUCH Historical