severe cold and flu daytime

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name severe cold and flu daytime
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler kroger company
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, guaifenesin 400 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
KROGER COMPANY

Identifiers & Regulatory

Product NDC 41226-780
Product ID 41226-780_167122ff-90c5-7e8b-e063-6394a90a7b8a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-04-30

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 41226780
Hyphenated Format 41226-780

Supplemental Identifiers

RxCUI
1369842
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 cold and flu daytime (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 400 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 354 mL in 1 BOTTLE (41226-780-01)
source: ndc

Packages (1)

41226-780-01 354 mL in 1 BOTTLE (41226-780-01)

Ingredients (4)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) guaifenesin (400 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Severe Cold and Flu Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "167122ff-90c5-7e8b-e063-6394a90a7b8a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1369842"], "spl_set_id": ["10106c90-f2f0-508e-e063-6294a90a544b"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["KROGER COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "354 mL in 1 BOTTLE (41226-780-01)", "package_ndc": "41226-780-01", "marketing_start_date": "20240430"}], "brand_name": "Severe Cold and Flu Daytime", "product_id": "41226-780_167122ff-90c5-7e8b-e063-6394a90a7b8a", "dosage_form": "LIQUID", "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": "41226-780", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "KROGER COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Cold and Flu Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240430", "listing_expiration_date": "20261231"}