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 43 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coated Aspirin ASPIRIN L.N.K. International, Inc. e077fe14-62bb-462b-bfa3-8a83c06c22f1 2025-07-11 Warnings Exact identifier application number: M013 EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TIME CAP LABS 59482917-f80b-4bed-9218-068b35366eb3 2025-07-11 Warnings Exact identifier application number: M013 Up and Up Childrens acetaminophen ACETAMINOPHEN Target Corporation 25a476a4-9969-49b3-94bf-b076bada4cea 2025-07-10 Warnings Exact identifier application number: M013 Tylenol Extra Strength Caplet ACETAMINOPHEN Jones Healthcare Group - Packaging Services, Inc fba711c1-4e69-49b0-8994-97c455aebcb2 2025-07-09 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN L. Perrigo Company af7ae548-38ad-41d5-b1cb-761cd2e386d3 2025-07-08 Warnings Exact identifier application number: M013 topcare pain relief ACETAMINOPHEN Topco Associates LLC 6aca88df-d3b5-4a60-b23b-1e66dc41ee7b 2025-07-08 Warnings Exact identifier application number: M013 equate childrens pain and fever ACETAMINOPHEN Wal-Mart Stores Inc f15037a5-4e43-4dd6-93b8-b37a1cc22cd6 2025-07-07 Warnings Exact identifier application number: M013 Childrens Acetaminophen Oral Liquid Grape Flavor ACETAMINOPHEN AARNA USA INC. 39347f5d-2d3c-0c23-e063-6294a90a3a46 2025-07-05 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc be841460-98b4-4448-a494-09ff161fd131 2025-07-02 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN Advanced Rx LLC ad0d6a5c-eee9-406c-8d7f-1df9b45f5340 2025-07-02 Warnings Exact identifier application number: M013 EXTRA STRENGHT HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE Lil' Drug Store Products, Inc. ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 2025-07-02 Warnings Exact identifier application number: M013 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE Genexa Inc. 18835205-a9e3-15c2-e063-6394a90a8107 2025-07-02 Warnings Exact identifier application number: M013 FeverAll ACETAMINOPHEN Sun Pharmaceutical Industries, Inc. 8970b91b-5f3c-4764-9e23-25dcb398d0a7 2025-07-02 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 11c9712d-c3b2-49cd-9c2b-0f57190c954e 2025-07-02 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN United Natural Foods, Inc. dba UNFI 979973c1-661a-4384-8b92-fd901ebde558 2025-07-01 Warnings Exact identifier application number: M013 Pain and Fever Childrens ACETAMINOPHEN CVS Pharmacy f6bbce1c-9790-4ca4-847f-579c594ffe0b 2025-07-01 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS 07d2e322-2465-79e5-e063-6294a90a5ea4 2025-06-30 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 66c0cf26-357b-4722-9100-3b86d507a8cd 2025-06-30 Warnings Exact identifier application number: M013 ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE Kroger Company bc019c9e-8fac-5fd3-e053-2a95a90a7ccd 2025-06-25 Warnings Exact identifier application number: M013 ACETAMINOPHEN Extra Strength ACETAMINOPHEN TIME CAP LABS INC fd24d0e0-4f36-42d3-9149-2fb957690305 2025-06-25 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