tylenol pm extra strength

Generic: acetaminophen and diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name tylenol pm extra strength
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-608
Product ID 50580-608_22eb873f-7035-d7ea-e063-6394a90afee2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2016-07-11

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580608
Hyphenated Format 50580-608

Supplemental Identifiers

RxCUI
1092189 1092378
UNII
362O9ITL9D TC2D6JAD40

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 pm extra strength (source: ndc)
Generic Name acetaminophen and diphenhydramine hydrochloride (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-608-01) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-608-02) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-608-03) / 150 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-608-04) / 225 TABLET, FILM COATED in 1 BOTTLE
  • 2 TABLET, FILM COATED in 1 POUCH (50580-608-05)
  • 50 POUCH in 1 TRAY (50580-608-06) / 2 TABLET, FILM COATED in 1 POUCH
  • 2 POUCH in 1 CARTON (50580-608-07) / 2 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE in 1 CARTON (50580-608-08) / 50 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (8)

50580-608-01 1 BOTTLE in 1 CARTON (50580-608-01) / 24 TABLET, FILM COATED in 1 BOTTLE 50580-608-02 1 BOTTLE in 1 CARTON (50580-608-02) / 100 TABLET, FILM COATED in 1 BOTTLE 50580-608-03 1 BOTTLE in 1 CARTON (50580-608-03) / 150 TABLET, FILM COATED in 1 BOTTLE 50580-608-04 1 BOTTLE in 1 CARTON (50580-608-04) / 225 TABLET, FILM COATED in 1 BOTTLE 50580-608-05 2 TABLET, FILM COATED in 1 POUCH (50580-608-05) 50580-608-06 50 POUCH in 1 TRAY (50580-608-06) / 2 TABLET, FILM COATED in 1 POUCH 50580-608-07 2 POUCH in 1 CARTON (50580-608-07) / 2 TABLET, FILM COATED in 1 POUCH 50580-608-08 1 BOTTLE in 1 CARTON (50580-608-08) / 50 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Tylenol PM Extra Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "22eb873f-7035-d7ea-e063-6394a90afee2", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189", "1092378"], "spl_set_id": ["ce58105b-f010-47af-8f31-6dd4ce4e9cba"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-608-01)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-608-01", "marketing_start_date": "20160711"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-608-02)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-608-02", "marketing_start_date": "20160711"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-608-03)  / 150 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-608-03", "marketing_start_date": "20160711"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-608-04)  / 225 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-608-04", "marketing_start_date": "20160711"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 POUCH (50580-608-05)", "package_ndc": "50580-608-05", "marketing_start_date": "20160711"}, {"sample": false, "description": "50 POUCH in 1 TRAY (50580-608-06)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-608-06", "marketing_start_date": "20160711"}, {"sample": false, "description": "2 POUCH in 1 CARTON (50580-608-07)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-608-07", "marketing_start_date": "20220214"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-608-08)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-608-08", "marketing_start_date": "20220601"}], "brand_name": "Tylenol PM Extra Strength", "product_id": "50580-608_22eb873f-7035-d7ea-e063-6394a90afee2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-608", "generic_name": "acetaminophen and diphenhydramine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol PM", "brand_name_suffix": "Extra Strength", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160711", "listing_expiration_date": "20261231"}