tylenol cold plus flu severe and tylenol cold max copack

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name tylenol cold plus flu severe and tylenol cold max copack
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form KIT
Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-231
Product ID 50580-231_21d497dd-b70b-cd96-e063-6294a90afcd9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-08-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580231
Hyphenated Format 50580-231

Supplemental Identifiers

RxCUI
1369842 1431245 2637731
UPC
0300450269089

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 tylenol cold plus flu severe and tylenol cold max copack (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)

Resolved Composition

Strengths
  • 30 ml
  • 650 mg
  • 20 mg
  • 400 mg
  • 10 mg
  • 15 ml
  • 325 mg
  • 6.25 mg
  • 5 mg
source: label
Packaging
  • 1 KIT in 1 PACKAGE (50580-231-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) * 240 mL in 1 BOTTLE, PLASTIC (50580-571-01)
source: ndc

Packages (1)

50580-231-01 1 KIT in 1 PACKAGE (50580-231-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) * 240 mL in 1 BOTTLE, PLASTIC (50580-571-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "21d497dd-b70b-cd96-e063-6294a90afcd9", "openfda": {"upc": ["0300450269089"], "rxcui": ["1369842", "1431245", "2637731"], "spl_set_id": ["657a1e59-104c-4152-b2c9-00a8b82dc78e"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE (50580-231-01)  *  240 mL in 1 BOTTLE, PLASTIC (50580-403-08)  *  240 mL in 1 BOTTLE, PLASTIC (50580-571-01)", "package_ndc": "50580-231-01", "marketing_start_date": "20180820"}], "brand_name": "TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack", "product_id": "50580-231_21d497dd-b70b-cd96-e063-6294a90afcd9", "dosage_form": "KIT", "product_ndc": "50580-231", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack", "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180820", "listing_expiration_date": "20261231"}