tukol max action cold, flu and sore throat

Generic: acetaminophen, 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 max action cold, flu and sore throat
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler genomma lab usa
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 32.5 mg/mL, dextromethorphan hydrobromide 1 mg/mL, guaifenesin 20 mg/mL, phenylephrine hydrochloride .5 mg/mL

Manufacturer
Genomma Lab USA

Identifiers & Regulatory

Product NDC 50066-313
Product ID 50066-313_f08e85d5-e94d-495d-ba72-523f794052c7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-06-21

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 50066313
Hyphenated Format 50066-313

Supplemental Identifiers

RxCUI
1116572
UNII
362O9ITL9D 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 cold, flu and sore throat (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 32.5 mg/mL
  • 1 mg/mL
  • 20 mg/mL
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50066-313-06) / 177 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50066-313-06 1 BOTTLE, PLASTIC in 1 CARTON (50066-313-06) / 177 mL in 1 BOTTLE, PLASTIC

Ingredients (4)

acetaminophen (32.5 mg/mL) dextromethorphan hydrobromide (1 mg/mL) guaifenesin (20 mg/mL) phenylephrine hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Tukol Max Action Cold, Flu and Sore Throat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f08e85d5-e94d-495d-ba72-523f794052c7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["aedce1f9-4902-4c51-92e0-6056196394c2"], "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 (50066-313-06)  / 177 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50066-313-06", "marketing_start_date": "20240621"}], "brand_name": "Tukol Max Action Cold, Flu and Sore Throat", "product_id": "50066-313_f08e85d5-e94d-495d-ba72-523f794052c7", "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": "50066-313", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Genomma Lab USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tukol Max Action Cold, Flu and Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "32.5 mg/mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "1 mg/mL"}, {"name": "GUAIFENESIN", "strength": "20 mg/mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240621", "listing_expiration_date": "20261231"}