tussnex fm cold and sinus

Generic: acteaminophen, guaifenesin, phenylephrine hcl

Labeler: guardian drug company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tussnex fm cold and sinus
Generic Name acteaminophen, guaifenesin, phenylephrine hcl
Labeler guardian drug company
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-616
Product ID 53041-616_3e372558-1578-4c25-962a-43af6b54de75
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-12-01

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 53041616
Hyphenated Format 53041-616

Supplemental Identifiers

RxCUI
1116568
UNII
362O9ITL9D 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 tussnex fm cold and sinus (source: ndc)
Generic Name acteaminophen, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 400 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (53041-616-58)
source: ndc

Packages (1)

53041-616-58 177 mL in 1 BOTTLE (53041-616-58)

Ingredients (3)

acetaminophen (650 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Tussnex FM Cold and Sinus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e372558-1578-4c25-962a-43af6b54de75", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116568"], "spl_set_id": ["04c6bb6a-d2f8-4322-afba-e240e8090176"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (53041-616-58)", "package_ndc": "53041-616-58", "marketing_start_date": "20121201"}], "brand_name": "Tussnex FM Cold and Sinus", "product_id": "53041-616_3e372558-1578-4c25-962a-43af6b54de75", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53041-616", "generic_name": "Acteaminophen, Guaifenesin, Phenylephrine HCl", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tussnex FM Cold and Sinus", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 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": "20121201", "listing_expiration_date": "20261231"}