tukol max action severe congestion and cough

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: genomma lab usa, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tukol max action severe congestion and cough
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler genomma lab usa, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Genomma Lab USA, Inc

Identifiers & Regulatory

Product NDC 50066-517
Product ID 50066-517_249ec14a-4df6-4fa2-e063-6294a90ad340
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-12-16

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 50066517
Hyphenated Format 50066-517

Supplemental Identifiers

RxCUI
1043543
UPC
0650067000255
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 tukol max action 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 (50066-517-25)
source: ndc

Packages (1)

50066-517-25 177 mL in 1 BOTTLE (50066-517-25)

Ingredients (3)

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

Linked Drug Pages (1)

Tukol MAX ACTION Severe Congestion and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "249ec14a-4df6-4fa2-e063-6294a90ad340", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0650067000255"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1043543"], "spl_set_id": ["9ac3e24a-d18a-48fc-8005-55393085d57b"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Genomma Lab USA, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (50066-517-25)", "package_ndc": "50066-517-25", "marketing_start_date": "20161216"}], "brand_name": "Tukol MAX ACTION Severe Congestion and Cough", "product_id": "50066-517_249ec14a-4df6-4fa2-e063-6294a90ad340", "dosage_form": "LIQUID", "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": "50066-517", "generic_name": "DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL", "labeler_name": "Genomma Lab USA, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tukol MAX ACTION 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": "20161216", "listing_expiration_date": "20261231"}