tylenol cold plus flu severe day/night

Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, 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 day/night
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form KIT
Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-414
Product ID 50580-414_21ab6663-3be6-9926-e063-6294a90aa5db
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-07-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580414
Hyphenated Format 50580-414

Supplemental Identifiers

RxCUI
1086991 1110988 2634819

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 day/night (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)

Resolved Composition

Strengths
  • 325 mg
  • 2 mg
  • 10 mg
  • 5 mg
  • 200 mg
source: label
Packaging
  • 3 CARTON in 1 CELLO PACK (50580-414-03) / 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

50580-414-03 3 CARTON in 1 CELLO PACK (50580-414-03) / 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK 50580-414-04 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "21ab6663-3be6-9926-e063-6294a90aa5db", "openfda": {"rxcui": ["1086991", "1110988", "2634819"], "spl_set_id": ["2ddb86a8-e34c-4a03-a60a-d3fedaf90608"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CARTON in 1 CELLO PACK (50580-414-03)  / 1 KIT in 1 CARTON (50580-414-04)  *  2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK *  2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-414-03", "marketing_start_date": "20160718"}, {"sample": false, "description": "1 KIT in 1 CARTON (50580-414-04)  *  2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK *  2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-414-04", "marketing_start_date": "20181221"}], "brand_name": "TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT", "product_id": "50580-414_21ab6663-3be6-9926-e063-6294a90aa5db", "dosage_form": "KIT", "product_ndc": "50580-414", "generic_name": "acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT", "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160718", "listing_expiration_date": "20261231"}