tylenol pm extra strength

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: navajo manufacturing company inc.
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 navajo manufacturing company inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Navajo Manufacturing Company Inc.

Identifiers & Regulatory

Product NDC 67751-241
Product ID 67751-241_435b2b2a-6d47-1611-e063-6394a90a9f99
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-03-11

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 67751241
Hyphenated Format 67751-241

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
  • 1 POUCH in 1 CARTON (67751-241-01) / 2 TABLET, FILM COATED in 1 POUCH
  • 2 POUCH in 1 CARTON (67751-241-02) / 2 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (2)

67751-241-01 1 POUCH in 1 CARTON (67751-241-01) / 2 TABLET, FILM COATED in 1 POUCH 67751-241-02 2 POUCH in 1 CARTON (67751-241-02) / 2 TABLET, FILM COATED in 1 POUCH

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": "435b2b2a-6d47-1611-e063-6394a90a9f99", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189", "1092378"], "spl_set_id": ["435b1a31-353d-af20-e063-6294a90aa907"], "manufacturer_name": ["Navajo Manufacturing Company Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (67751-241-01)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "67751-241-01", "marketing_start_date": "20250311"}, {"sample": false, "description": "2 POUCH in 1 CARTON (67751-241-02)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "67751-241-02", "marketing_start_date": "20250923"}], "brand_name": "Tylenol PM Extra Strength", "product_id": "67751-241_435b2b2a-6d47-1611-e063-6394a90a9f99", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "67751-241", "generic_name": "acetaminophen and diphenhydramine hydrochloride", "labeler_name": "Navajo Manufacturing Company Inc.", "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": "20250311", "listing_expiration_date": "20261231"}