severe nighttime cold and flu

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

Labeler: walgreens
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe nighttime cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
Labeler walgreens
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
WALGREENS

Identifiers & Regulatory

Product NDC 0363-8997
Product ID 0363-8997_48c20cda-6e87-4946-e063-6394a90a9c05
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2021-08-23
Marketing End 2026-11-30

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 03638997
Hyphenated Format 0363-8997

Supplemental Identifiers

RxCUI
1297288
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 severe nighttime 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
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0363-8997-24) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0363-8997-24 2 BLISTER PACK in 1 CARTON (0363-8997-24) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

SEVERE NIGHTTIME COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48c20cda-6e87-4946-e063-6394a90a9c05", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1297288"], "spl_set_id": ["fe6dff90-18f1-491e-84b9-cc74bb1831ba"], "manufacturer_name": ["WALGREENS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0363-8997-24)  / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK", "package_ndc": "0363-8997-24", "marketing_end_date": "20261130", "marketing_start_date": "20210823"}], "brand_name": "SEVERE NIGHTTIME COLD AND FLU", "product_id": "0363-8997_48c20cda-6e87-4946-e063-6394a90a9c05", "dosage_form": "CAPSULE, GELATIN COATED", "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": "0363-8997", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "WALGREENS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SEVERE NIGHTTIME COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261130", "marketing_start_date": "20210823"}