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 47 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD REMEDIES Extra Strength Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d642d8e-c154-a970-e063-6294a90a03bf 2025-03-14 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4 2025-03-07 Warnings Exact identifier application number: M013 Redicare Non-Aspirin 500mg REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG Redicare LLC 2f229898-1777-732c-e063-6394a90a76bc 2025-03-04 Warnings, Adverse reactions Exact identifier application number: M013 Major Extra Strength Acetaminophen Liquid ACETAMINOPHEN Major Pharmaceuticals 2f3af4dd-45d5-87b4-e063-6294a90ab3cc 2025-02-28 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs ed9a71d6-a56e-416a-bb89-6d41307efc5a 2025-02-27 Warnings Exact identifier application number: M013 Aspirin ASPIRIN PD-Rx Pharmaceuticals, Inc. 77429b7f-78e4-42c0-8679-ae8da1748848 2025-02-26 Warnings Exact identifier application number: M013 AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES Aero Healthcare faa3a4ef-3c70-06ca-e053-6394a90a512d 2025-02-26 Warnings Exact identifier application number: M013 Bufferin Regular Strength Pain Relief ASPIRIN Genomma Lab USA 3543b2bf-1062-468a-a5dc-eabb2408af8c 2025-02-25 Warnings Exact identifier application number: M013 Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CHEWABLE 80 MG Calmour ae47b027-4f29-45bb-a8bd-812978932835 2025-02-22 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC f9de7c2f-016b-4f40-8b5e-141ad194be97 2025-02-20 Warnings Exact identifier application number: M013 Genexa Acetaminophen PM Extra Strength ACETAMINOPHEN Genexa Inc. d82cf6f3-a291-ca2b-e053-2a95a90a6de1 2025-02-20 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Advagen Pharma Limited 8b9456c9-a56b-4748-adb8-c66d6bf072e8 2025-02-19 Warnings Exact identifier application number: M013 Genexa Childrens Acetaminophen ACETAMINOPHEN Genexa Inc. d89fd9d8-d88e-3968-e053-2a95a90afc5f 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. debfa787-7a48-48b5-94b0-612820524032 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. b16e5dcf-b290-4ff2-a150-4b875647ec9a 2025-02-19 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC bb6533e5-e6a9-488c-b8ab-a6a06e87ede9 2025-02-18 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC c830320e-72ba-48ff-a4cd-250ac5650bf0 2025-02-18 Warnings Exact identifier application number: M013 Aspirina Caplets ASPIRIN Bayer HealthCare LLC. 2e6f5ba8-8e8b-6059-e063-6394a90adcd5 2025-02-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. da7d95af-6583-429d-8d04-e0424f32e9ad 2025-02-17 Warnings Exact identifier application number: M013 GOODYS Mental Alert ASPIRIN AND CAFFEINE Medtech Products Inc. 31ef6d07-d314-4d09-abcd-389ba66cbcc5 2025-02-17 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 0280-1400-12 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