severe congestion and cough relief maximum strength

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: l.n.k. international, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe congestion and cough relief maximum strength
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler l.n.k. international, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
L.N.K. International, Inc.

Identifiers & Regulatory

Product NDC 50844-004
Product ID 50844-004_d2fb4630-827d-4478-b2c7-4f9820e6863f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-03-01

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 50844004
Hyphenated Format 50844-004

Supplemental Identifiers

RxCUI
1043543
UPC
0350844004451
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 relief maximum strength (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 (50844-004-45)
source: ndc

Packages (1)

50844-004-45 177 mL in 1 BOTTLE (50844-004-45)

Ingredients (3)

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

Linked Drug Pages (1)

Severe Congestion and Cough Relief Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d2fb4630-827d-4478-b2c7-4f9820e6863f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0350844004451"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1043543"], "spl_set_id": ["8141ddc5-2a25-4800-a465-58d3b45bceb0"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (50844-004-45)", "package_ndc": "50844-004-45", "marketing_start_date": "20170301"}], "brand_name": "Severe Congestion and Cough Relief Maximum Strength", "product_id": "50844-004_d2fb4630-827d-4478-b2c7-4f9820e6863f", "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": "50844-004", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Congestion and Cough Relief", "brand_name_suffix": "Maximum Strength", "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": "20170301", "listing_expiration_date": "20261231"}