cetafen cough and cold

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, ,

Labeler: hart health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cetafen cough and cold
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, ,
Labeler hart health
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 100 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
HART Health

Identifiers & Regulatory

Product NDC 50332-0141
Product ID 50332-0141_866ea7b4-cf9b-4001-a533-12b8f562e042
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M
Listing Expiration 2026-12-31
Marketing Start 2023-01-09

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 503320141
Hyphenated Format 50332-0141

Supplemental Identifiers

RxCUI
1098435
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 cetafen cough and cold (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , (source: ndc)
Application Number M (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 100 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 20 PACKET in 1 BAG (50332-0141-3) / 2 TABLET, FILM COATED in 1 PACKET
  • 40 PACKET in 1 BOX (50332-0141-4) / 2 TABLET, FILM COATED in 1 PACKET
  • 100 PACKET in 1 BOX (50332-0141-7) / 2 TABLET, FILM COATED in 1 PACKET
source: ndc

Packages (3)

50332-0141-3 20 PACKET in 1 BAG (50332-0141-3) / 2 TABLET, FILM COATED in 1 PACKET 50332-0141-4 40 PACKET in 1 BOX (50332-0141-4) / 2 TABLET, FILM COATED in 1 PACKET 50332-0141-7 100 PACKET in 1 BOX (50332-0141-7) / 2 TABLET, FILM COATED in 1 PACKET

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (100 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

CETAFEN COUGH and COLD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "866ea7b4-cf9b-4001-a533-12b8f562e042", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1098435"], "spl_set_id": ["44da0d8c-4a12-4122-99da-781e2809e1a8"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["HART Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 PACKET in 1 BAG (50332-0141-3)  / 2 TABLET, FILM COATED in 1 PACKET", "package_ndc": "50332-0141-3", "marketing_start_date": "20230109"}, {"sample": false, "description": "40 PACKET in 1 BOX (50332-0141-4)  / 2 TABLET, FILM COATED in 1 PACKET", "package_ndc": "50332-0141-4", "marketing_start_date": "20230109"}, {"sample": false, "description": "100 PACKET in 1 BOX (50332-0141-7)  / 2 TABLET, FILM COATED in 1 PACKET", "package_ndc": "50332-0141-7", "marketing_start_date": "20230109"}], "brand_name": "CETAFEN COUGH and COLD", "product_id": "50332-0141_866ea7b4-cf9b-4001-a533-12b8f562e042", "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": "50332-0141", "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,", "labeler_name": "HART Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CETAFEN COUGH and COLD", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "100 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230109", "listing_expiration_date": "20261231"}