extra strength tylenol severe cough plus sore throat night

Generic: acetaminophen, dextromethorphan hydrobromide and doxylamine succinate.

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name extra strength tylenol severe cough plus sore throat night
Generic Name acetaminophen, dextromethorphan hydrobromide and doxylamine succinate.
Labeler kenvue brands llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 1000 mg/30mL, dextromethorphan hydrobromide 30 mg/30mL, doxylamine succinate 12.5 mg/30mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-243
Product ID 50580-243_21d5b551-6600-0381-e063-6294a90a2985
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-06-19

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 50580243
Hyphenated Format 50580-243

Supplemental Identifiers

RxCUI
1042684
UPC
0300450522092
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 extra strength tylenol severe cough plus sore throat night (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide and doxylamine succinate. (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/30mL
  • 30 mg/30mL
  • 12.5 mg/30mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (50580-243-01)
source: ndc

Packages (1)

50580-243-01 240 mL in 1 BOTTLE (50580-243-01)

Ingredients (3)

acetaminophen (1000 mg/30mL) dextromethorphan hydrobromide (30 mg/30mL) doxylamine succinate (12.5 mg/30mL)

Linked Drug Pages (1)

Extra Strength TYLENOL Severe Cough Plus Sore Throat Night ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21d5b551-6600-0381-e063-6294a90a2985", "openfda": {"upc": ["0300450522092"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1042684"], "spl_set_id": ["f81d924e-10e9-0e9d-e053-6294a90a2ddf"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (50580-243-01)", "package_ndc": "50580-243-01", "marketing_start_date": "20230619"}], "brand_name": "Extra Strength TYLENOL Severe Cough Plus Sore Throat Night", "product_id": "50580-243_21d5b551-6600-0381-e063-6294a90a2985", "dosage_form": "LIQUID", "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": "50580-243", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate.", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Extra Strength TYLENOL Severe Cough Plus Sore Throat Night", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "1000 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230619", "listing_expiration_date": "20261231"}