severe daytime cold and flu daytime maximum strength non-drowsy severe

Generic: acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name severe daytime cold and flu daytime maximum strength non-drowsy severe
Generic Name acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride
Labeler walgreens
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Walgreens

Identifiers & Regulatory

Product NDC 0363-8996
Product ID 0363-8996_48c201e3-e57a-f0c2-e063-6294a90a95ca
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2021-08-23
Marketing End 2027-06-30

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03638996
Hyphenated Format 0363-8996

Supplemental Identifiers

RxCUI
1656815
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 daytime cold and flu daytime maximum strength non-drowsy severe (source: ndc)
Generic Name acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0363-8996-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

0363-8996-24 2 BLISTER PACK in 1 CARTON (0363-8996-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48c201e3-e57a-f0c2-e063-6294a90a95ca", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1656815"], "spl_set_id": ["ca3c1eb4-6099-5e5f-e053-2995a90ab61b"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Walgreens"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0363-8996-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0363-8996-24", "marketing_end_date": "20270630", "marketing_start_date": "20210823"}], "brand_name": "SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE", "product_id": "0363-8996_48c201e3-e57a-f0c2-e063-6294a90a95ca", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "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": "0363-8996", "generic_name": "ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Walgreens", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SEVERE DAYTIME COLD and FLU", "brand_name_suffix": "DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270630", "marketing_start_date": "20210823"}