tylenol cold plus flu severe

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

Labeler: morning star otc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tylenol cold plus flu severe
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler morning star otc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Morning Star OTC

Identifiers & Regulatory

Product NDC 53209-1003
Product ID 53209-1003_37e8b7f1-82e5-986b-e063-6394a90a07d7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-06-19

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 532091003
Hyphenated Format 53209-1003

Supplemental Identifiers

RxCUI
1110988
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 severe (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, 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
  • 25 BLISTER PACK in 1 POUCH (53209-1003-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1003-1)
source: ndc

Packages (1)

53209-1003-2 25 BLISTER PACK in 1 POUCH (53209-1003-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1003-1)

Ingredients (4)

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

Linked Drug Pages (1)

TYLENOL Cold Plus Flu Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37e8b7f1-82e5-986b-e063-6394a90a07d7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1110988"], "spl_set_id": ["be95332d-a2e0-42e8-bfb3-8850d74990ff"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Morning Star OTC"]}, "finished": true, "packaging": [{"sample": false, "description": "25 BLISTER PACK in 1 POUCH (53209-1003-2)  / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1003-1)", "package_ndc": "53209-1003-2", "marketing_start_date": "20250619"}], "brand_name": "TYLENOL Cold Plus Flu Severe", "product_id": "53209-1003_37e8b7f1-82e5-986b-e063-6394a90a07d7", "dosage_form": "TABLET, FILM COATED", "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": "53209-1003", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Morning Star OTC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TYLENOL Cold Plus Flu", "brand_name_suffix": "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_start_date": "20250619", "listing_expiration_date": "20261231"}