cold and flu severe

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold and flu severe
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl
Labeler walgreen company
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, phenylephrine hydrochloride 10 mg/20mL, triprolidine hydrochloride 2.5 mg/20mL

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-8078
Product ID 0363-8078_795ef8ac-48a0-4264-bf61-086522fc9a3b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-10-21

Pharmacologic Class

Classes
adrenergic alpha1-agonists [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 03638078
Hyphenated Format 0363-8078

Supplemental Identifiers

RxCUI
2173662
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ YAN7R5L890

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 cold and flu severe (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 20 mg/20mL
  • 10 mg/20mL
  • 2.5 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (0363-8078-45)
source: ndc

Packages (1)

0363-8078-45 177 mL in 1 BOTTLE, PLASTIC (0363-8078-45)

Ingredients (4)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) phenylephrine hydrochloride (10 mg/20mL) triprolidine hydrochloride (2.5 mg/20mL)

Linked Drug Pages (1)

Cold and Flu Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "795ef8ac-48a0-4264-bf61-086522fc9a3b", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ", "YAN7R5L890"], "rxcui": ["2173662"], "spl_set_id": ["0a48f650-ad2a-4105-9ff4-2bc4d94b46d3"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (0363-8078-45)", "package_ndc": "0363-8078-45", "marketing_start_date": "20231021"}], "brand_name": "Cold and Flu Severe", "product_id": "0363-8078_795ef8ac-48a0-4264-bf61-086522fc9a3b", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [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": "0363-8078", "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl", "labeler_name": "Walgreen Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu", "brand_name_suffix": "Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}, {"name": "TRIPROLIDINE HYDROCHLORIDE", "strength": "2.5 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231021", "listing_expiration_date": "20261231"}