tylenol cold plus flu plus cough night

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

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tylenol cold plus flu plus cough night
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, doxylamine succinate 6.25 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-369
Product ID 50580-369_21e8a73b-cb4a-6770-e063-6294a90a4a53
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-06-17

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 50580369
Hyphenated Format 50580-369

Supplemental Identifiers

RxCUI
1431245
UPC
0300450562081
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 tylenol cold plus flu plus cough night (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/15mL
  • 10 mg/15mL
  • 6.25 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (50580-369-01)
source: ndc

Packages (1)

50580-369-01 240 mL in 1 BOTTLE (50580-369-01)

Ingredients (4)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) doxylamine succinate (6.25 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (1)

Tylenol Cold plus Flu plus Cough Night ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21e8a73b-cb4a-6770-e063-6294a90a4a53", "openfda": {"upc": ["0300450562081"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1431245"], "spl_set_id": ["e85e5eb9-3ecf-4784-999e-111e38e306f5"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (50580-369-01)", "package_ndc": "50580-369-01", "marketing_start_date": "20190617"}], "brand_name": "Tylenol Cold plus Flu plus Cough Night", "product_id": "50580-369_21e8a73b-cb4a-6770-e063-6294a90a4a53", "dosage_form": "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": "50580-369", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol Cold plus Flu plus Cough", "brand_name_suffix": "Night", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190617", "listing_expiration_date": "20261231"}