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 46 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RIGHT REMEDIES LOW DOSE Aspirin 81mg ASPIRIN Strive Pharmaceuticals Inc. 322c0e50-cf75-51ab-e063-6294a90a9235 2025-04-14 Warnings Exact identifier application number: M013 Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange ASPIRIN Bayer HealthCare LLC. 0c6ae05f-760f-34d1-e054-00144ff88e88 2025-04-11 Warnings Exact identifier application number: M013 Arthriten Inflammatory Pain Formula ACETAMINOPHEN, ASPIRIN, CAFFEINE Kobayashi Healthcare International, Inc c280ca89-4fb5-4050-90ee-d706a550a1ef 2025-04-11 Warnings Exact identifier application number: M013 Bayer Back and Body Extra Strength ASPIRIN,CAFFEINE Bayer HealthCare LLC. 0c77c484-6caf-12ca-e054-00144ff88e88 2025-04-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN NuCare Pharmaceuticals, Inc. 324937c3-c558-bc79-e063-6294a90acc8e 2025-04-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Geri-Care Pharmaceutical Corp e327a52a-0e31-44b7-9823-7f60d070ae52 2025-04-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Exact identifier application number: M013 ASPIRIN 325 MG EC ASPIRIN Bryant Ranch Prepack 9d0449d2-c0c6-4e74-931b-35dc62584028 2025-03-31 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Bryant Ranch Prepack cce1e8bd-63c8-403a-bc32-e6788493f604 2025-03-31 Warnings Exact identifier application number: M013 Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL WR Group, Inc. 8281771c-485c-42a9-9a1c-9a7a4298c5b8 2025-03-28 Warnings Exact identifier application number: M013 Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 Warnings Exact identifier application number: M013 CounterAct Pain ACETAMINOPHEN Melaleuca, Inc. 7faf76b4-7f25-377d-e053-2a91aa0a19d4 2025-03-20 Boxed warning, Warnings Exact identifier application number: M013 Mejoral ACETAMINOPHEN, CAFFEINE OPMX LLC 0bccf571-fcb9-2dd5-e063-6294a90a5f16 2025-03-19 Warnings Exact identifier application number: M013 ARTRIFIN 24 CAPLETS ACETAMINOPHEN, ASPIRIN, CAFFEINE OPMX LLC e7f15c2b-a730-b54f-e053-2a95a90a3b3e 2025-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL TARGET Corporation 1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1 2025-03-17 Warnings Exact identifier application number: M013 Signature Select Effervescent Pain Relief ASPIRIN Safeway Inc. 304fca65-2867-c963-e063-6394a90a183f 2025-03-14 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