alka-seltzer plus cold night

Generic: aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name alka-seltzer plus cold night
Generic Name aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate
Labeler bayer healthcare llc.
Dosage Form TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients

aspirin 500 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1, phenylephrine bitartrate 7.8 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-1545
Product ID 0280-1545_45267736-ecae-d911-e063-6294a90a98bc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-09-14

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc] platelet aggregation inhibitor [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]
Physiologic Effect
decreased prostaglandin production [pe] decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02801545
Hyphenated Format 0280-1545

Supplemental Identifiers

RxCUI
1536503
UPC
0016500565000
UNII
R16CO5Y76E 9D2RTI9KYH V9BI9B5YI2 27O3Q5ML57
NUI
N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alka-seltzer plus cold night (source: ndc)
Generic Name aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 7.8 mg/1
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (0280-1545-20) / 2 TABLET, EFFERVESCENT in 1 POUCH
source: ndc

Packages (1)

0280-1545-20 10 POUCH in 1 CARTON (0280-1545-20) / 2 TABLET, EFFERVESCENT in 1 POUCH

Ingredients (4)

aspirin (500 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine bitartrate (7.8 mg/1)

Linked Drug Pages (1)

Alka-Seltzer Plus Cold Night ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45267736-ecae-d911-e063-6294a90a98bc", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832"], "upc": ["0016500565000"], "unii": ["R16CO5Y76E", "9D2RTI9KYH", "V9BI9B5YI2", "27O3Q5ML57"], "rxcui": ["1536503"], "spl_set_id": ["7588ea67-68a9-4dc0-e053-2991aa0aa471"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_pe": ["Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (0280-1545-20)  / 2 TABLET, EFFERVESCENT in 1 POUCH", "package_ndc": "0280-1545-20", "marketing_start_date": "20180914"}], "brand_name": "Alka-Seltzer Plus Cold Night", "product_id": "0280-1545_45267736-ecae-d911-e063-6294a90a98bc", "dosage_form": "TABLET, EFFERVESCENT", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Antihistamine [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "Decreased Prostaglandin Production [PE]", "Histamine Receptor Antagonists [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "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]"], "product_ndc": "0280-1545", "generic_name": "Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka-Seltzer Plus Cold Night", "active_ingredients": [{"name": "ASPIRIN", "strength": "500 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE BITARTRATE", "strength": "7.8 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180914", "listing_expiration_date": "20261231"}