severe congestion and cough

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: family dollar services inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe congestion and cough
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler family dollar services inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Family Dollar Services Inc

Identifiers & Regulatory

Product NDC 55319-204
Product ID 55319-204_855c21ba-8243-43c4-8c75-b7cbff43159f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2024-01-04

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 55319204
Hyphenated Format 55319-204

Supplemental Identifiers

RxCUI
1043543
UPC
0032251923807
UNII
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 congestion and cough (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 400 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (55319-204-45)
source: ndc

Packages (1)

55319-204-45 177 mL in 1 BOTTLE, PLASTIC (55319-204-45)

Ingredients (3)

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

Linked Drug Pages (1)

Severe Congestion and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "855c21ba-8243-43c4-8c75-b7cbff43159f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0032251923807"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1043543"], "spl_set_id": ["b9215a5e-3be8-44fd-9189-50dab760869c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Family Dollar Services Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (55319-204-45)", "package_ndc": "55319-204-45", "marketing_start_date": "20240104"}], "brand_name": "Severe Congestion and Cough", "product_id": "55319-204_855c21ba-8243-43c4-8c75-b7cbff43159f", "dosage_form": "SOLUTION", "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": "55319-204", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Family Dollar Services Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Congestion and Cough", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240104", "listing_expiration_date": "20271231"}