tylenol pm extra strength

Generic: acetaminophen, diphenhydramine hydrochloride

Labeler: jones healthcare group - packaging services, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tylenol pm extra strength
Generic Name acetaminophen, diphenhydramine hydrochloride
Labeler jones healthcare group - packaging services, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Jones Healthcare Group - Packaging Services, Inc

Identifiers & Regulatory

Product NDC 67414-608
Product ID 67414-608_20aec2bd-9934-370f-e063-6294a90a2bae
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2018-01-25

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 67414608
Hyphenated Format 67414-608

Supplemental Identifiers

RxCUI
1092189 1092378
UPC
0300450482389
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, 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
  • 2500 POUCH in 1 BOX (67414-608-00) / 2 TABLET, FILM COATED in 1 POUCH
  • 50 POUCH in 1 TRAY (67414-608-06) / 2 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (2)

67414-608-00 2500 POUCH in 1 BOX (67414-608-00) / 2 TABLET, FILM COATED in 1 POUCH 67414-608-06 50 POUCH in 1 TRAY (67414-608-06) / 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": "20aec2bd-9934-370f-e063-6294a90a2bae", "openfda": {"upc": ["0300450482389"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189", "1092378"], "spl_set_id": ["639f4e01-9723-a619-e053-2991aa0a549a"], "manufacturer_name": ["Jones Healthcare Group - Packaging Services, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2500 POUCH in 1 BOX (67414-608-00)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "67414-608-00", "marketing_start_date": "20180125"}, {"sample": false, "description": "50 POUCH in 1 TRAY (67414-608-06)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "67414-608-06", "marketing_start_date": "20180125"}], "brand_name": "Tylenol PM Extra Strength", "product_id": "67414-608_20aec2bd-9934-370f-e063-6294a90a2bae", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "67414-608", "generic_name": "ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Jones Healthcare Group - Packaging Services, 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": "20180125", "listing_expiration_date": "20261231"}