tukol sugar free cough and cold

Generic: dextromethorphan hydrobromide and guaifenesin

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

Drug Facts

Product Profile

Brand Name tukol sugar free cough and cold
Generic Name dextromethorphan hydrobromide and guaifenesin
Labeler genomma lab usa
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 2 mg/mL, guaifenesin 20 mg/mL

Manufacturer
Genomma Lab USA

Identifiers & Regulatory

Product NDC 50066-505
Product ID 50066-505_23f8271b-e6f1-8897-e063-6394a90a9c82
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-06-13

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 50066505
Hyphenated Format 50066-505

Supplemental Identifiers

RxCUI
996520
UNII
9D2RTI9KYH 495W7451VQ
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 sugar free cough and cold (source: ndc)
Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50066-505-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50066-505-04 1 BOTTLE, PLASTIC in 1 CARTON (50066-505-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (2 mg/mL) guaifenesin (20 mg/mL)

Linked Drug Pages (1)

Tukol Sugar Free Cough and Cold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "23f8271b-e6f1-8897-e063-6394a90a9c82", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841"], "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 (50066-505-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50066-505-04", "marketing_start_date": "20240613"}], "brand_name": "Tukol Sugar Free Cough and Cold", "product_id": "50066-505_23f8271b-e6f1-8897-e063-6394a90a9c82", "dosage_form": "SYRUP", "pharm_class": ["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]"], "product_ndc": "50066-505", "generic_name": "Dextromethorphan Hydrobromide and Guaifenesin", "labeler_name": "Genomma Lab USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tukol Sugar Free Cough and Cold", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "2 mg/mL"}, {"name": "GUAIFENESIN", "strength": "20 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240613", "listing_expiration_date": "20261231"}