tukol honey children cough and congestion (50066-301)

Drug Facts

Product Profile

Brand Name tukol honey children cough and congestion

Generic Name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Labeler genomma lab usa

Dosage Form SYRUP

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 5 mg/2.5mL, guaifenesin 50 mg/2.5mL, phenylephrine hydrochloride 2.5 mg/2.5mL

Manufacturer

Genomma Lab USA

Identifiers & Regulatory

Product NDC 50066-301

Product ID 50066-301_24c1f740-5460-0dad-e063-6394a90a8fa0

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2020-02-09

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 50066301

Hyphenated Format 50066-301

Supplemental Identifiers

RxCUI

1044949

UPC

0650240051258

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 honey children 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

5 mg/2.5mL
50 mg/2.5mL
2.5 mg/2.5mL

source: ndc

Packaging

1 BOTTLE, PLASTIC in 1 CARTON (50066-301-04) / 118 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

50066-301-04 1 BOTTLE, PLASTIC in 1 CARTON (50066-301-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

dextromethorphan hydrobromide (5 mg/2.5mL) guaifenesin (50 mg/2.5mL) phenylephrine hydrochloride (2.5 mg/2.5mL)

Linked Drug Pages (1)

Tukol Honey Children Cough and Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "24c1f740-5460-0dad-e063-6394a90a8fa0", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0650240051258"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1044949"], "spl_set_id": ["dae33df8-2294-4242-a25b-2d89d1f63b23"], "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 (50066-301-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50066-301-04", "marketing_start_date": "20200209"}], "brand_name": "Tukol Honey Children Cough and Congestion", "product_id": "50066-301_24c1f740-5460-0dad-e063-6394a90a8fa0", "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": "50066-301", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Genomma Lab USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tukol Honey Children Cough and Congestion", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/2.5mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/2.5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/2.5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200209", "listing_expiration_date": "20261231"}