tukol cough and congestion

Generic: dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name tukol cough and congestion
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler genomma lab usa
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Genomma Lab USA

Identifiers & Regulatory

Product NDC 50066-510
Product ID 50066-510_247097cf-c927-d77a-e063-6394a90a5a19
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-06-07

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 50066510
Hyphenated Format 50066-510

Supplemental Identifiers

RxCUI
1044949
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 cough and congestion (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50066-510-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50066-510-04 1 BOTTLE, PLASTIC in 1 CARTON (50066-510-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Tukol Cough and Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "247097cf-c927-d77a-e063-6394a90a5a19", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1044949"], "spl_set_id": ["27ab3d86-e960-4d83-aad1-d50d2c8e02a9"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Genomma Lab USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50066-510-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50066-510-04", "marketing_start_date": "20200607"}], "brand_name": "Tukol Cough and Congestion", "product_id": "50066-510_247097cf-c927-d77a-e063-6394a90a5a19", "dosage_form": "SYRUP", "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": "50066-510", "generic_name": "Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Genomma Lab USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tukol Cough and Congestion", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200607", "listing_expiration_date": "20261231"}