tukol honey nighttime cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate

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

Drug Facts

Product Profile

Brand Name tukol honey nighttime cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
Labeler genomma lab usa
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 21.667 mg/mL, dextromethorphan hydrobromide 1 mg/mL, doxylamine succinate .4167 mg/mL

Manufacturer
Genomma Lab USA

Identifiers & Regulatory

Product NDC 50066-303
Product ID 50066-303_24fec102-30d8-373f-e063-6394a90ac8ab
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

Classes
antihistamine [epc] histamine receptor antagonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50066303
Hyphenated Format 50066-303

Supplemental Identifiers

RxCUI
1043400
UPC
0650240051241
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2

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 nighttime cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 21.667 mg/mL
  • 1 mg/mL
  • .4167 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50066-303-04 1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

acetaminophen (21.667 mg/mL) dextromethorphan hydrobromide (1 mg/mL) doxylamine succinate (.4167 mg/mL)

Linked Drug Pages (1)

Tukol Honey Nighttime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24fec102-30d8-373f-e063-6394a90ac8ab", "openfda": {"upc": ["0650240051241"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["bf25f38e-3549-4f78-be90-46605b5f2c11"], "manufacturer_name": ["Genomma Lab USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50066-303-04", "marketing_start_date": "20200209"}], "brand_name": "Tukol Honey Nighttime Cold and Flu", "product_id": "50066-303_24fec102-30d8-373f-e063-6394a90ac8ab", "dosage_form": "SYRUP", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "50066-303", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE", "labeler_name": "Genomma Lab USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tukol Honey Nighttime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "21.667 mg/mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "1 mg/mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": ".4167 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200209", "listing_expiration_date": "20261231"}