alka-seltzer plus night severe cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name alka-seltzer plus night severe cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
Labeler bayer healthcare llc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, dextromethorphan hydrobromide 20 mg/1, doxylamine succinate 12.5 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0922
Product ID 0280-0922_47e3298a-8540-598c-e063-6294a90ada28
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2014-04-17

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] antihistamine [epc] histamine receptor antagonists [moa] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02800922
Hyphenated Format 0280-0922

Supplemental Identifiers

RxCUI
1534835
UPC
0016500559399
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 04JA59TNSJ

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 night severe cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 20 mg/1
  • 12.5 mg/1
  • 10 mg/1
source: ndc
Packaging
  • PRINCIPAL DISPLAY PANEL - 6 Packet Carton Alka-Seltzer PLUS ® Severe Cold & Flu Honey Lemon Zest Fast Relief Mix-In Packets Night Acetaminophen / Pain reliever-fever reducer Doxylamine succinate / Antihistamine Phenylephrine HCl / Nasal decongestant Dextromethorphan HBr / Cough suppressant • Nasal Congestion • Headache • Sore Throat • Body Ache • Cough • Runny Nose • Fever 6 PACKETS Carton 6 packets
source: label

Packages (0)

No package records.

Ingredients (4)

acetaminophen (650 mg/1) dextromethorphan hydrobromide (20 mg/1) doxylamine succinate (12.5 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47e3298a-8540-598c-e063-6294a90ada28", "openfda": {"upc": ["0016500559399"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1534835"], "spl_set_id": ["f4c60ca1-ba59-4a92-84a5-6ba65faa56ab"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Alka-Seltzer Plus Night Severe Cold and Flu", "product_id": "0280-0922_47e3298a-8540-598c-e063-6294a90ada28", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "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": "0280-0922", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka-Seltzer Plus Night Severe Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140417", "listing_expiration_date": "20271231"}