tylenol pm extra strength

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: morning star otc
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 morning star otc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Morning Star OTC

Identifiers & Regulatory

Product NDC 53209-1002
Product ID 53209-1002_37e8f74e-9c3f-b0e7-e063-6394a90a5106
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-06-19

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 532091002
Hyphenated Format 53209-1002

Supplemental Identifiers

RxCUI
1092189 1092378
UNII
362O9ITL9D TC2D6JAD40

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
  • 25 BLISTER PACK in 1 POUCH (53209-1002-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1002-1)
source: ndc

Packages (1)

53209-1002-2 25 BLISTER PACK in 1 POUCH (53209-1002-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1002-1)

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": "37e8f74e-9c3f-b0e7-e063-6394a90a5106", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189", "1092378"], "spl_set_id": ["6cd07a01-7034-4994-bbd3-bedcdf7d5b83"], "manufacturer_name": ["Morning Star OTC"]}, "finished": true, "packaging": [{"sample": false, "description": "25 BLISTER PACK in 1 POUCH (53209-1002-2)  / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1002-1)", "package_ndc": "53209-1002-2", "marketing_start_date": "20250619"}], "brand_name": "Tylenol PM Extra Strength", "product_id": "53209-1002_37e8f74e-9c3f-b0e7-e063-6394a90a5106", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53209-1002", "generic_name": "acetaminophen and diphenhydramine hydrochloride", "labeler_name": "Morning Star OTC", "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": "20250619", "listing_expiration_date": "20261231"}