tukol a

Generic: dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name tukol a
Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Labeler genomma lab usa, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Genomma Lab USA, Inc.

Identifiers & Regulatory

Product NDC 50066-536
Product ID 50066-536_158e568c-c1da-4e77-a6a4-34062f86f1fc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part341
Listing Expiration 2026-12-31
Marketing Start 2014-06-09

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 50066536
Hyphenated Format 50066-536

Supplemental Identifiers

RxCUI
1370205
UPC
0650066000539
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 a (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)
Application Number part341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 50 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (50066-536-24)
source: ndc

Packages (1)

50066-536-24 118 mL in 1 BOTTLE (50066-536-24)

Ingredients (3)

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

Linked Drug Pages (1)

Tukol A ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "158e568c-c1da-4e77-a6a4-34062f86f1fc", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0650066000539"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1370205"], "spl_set_id": ["651f0d7c-c76b-434d-95fd-427609b40b46"], "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": "118 mL in 1 BOTTLE (50066-536-24)", "package_ndc": "50066-536-24", "marketing_start_date": "20140609"}], "brand_name": "Tukol A", "product_id": "50066-536_158e568c-c1da-4e77-a6a4-34062f86f1fc", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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": "50066-536", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Genomma Lab USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tukol A", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "part341", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20140609", "listing_expiration_date": "20261231"}