acetaminophen pm extra strength

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: united natural foods, inc. dba unfi
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen pm extra strength
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler united natural foods, inc. dba unfi
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
United Natural Foods, Inc. dba UNFI

Identifiers & Regulatory

Product NDC 41163-515
Product ID 41163-515_24b11c3b-9c19-ff00-e063-6394a90adbed
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2014-09-01

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 41163515
Hyphenated Format 41163-515

Supplemental Identifiers

RxCUI
1092189
UPC
0041163488243
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 acetaminophen 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, PLASTIC in 1 CARTON (41163-515-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (41163-515-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

41163-515-01 1 BOTTLE, PLASTIC in 1 CARTON (41163-515-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 41163-515-03 1 BOTTLE, PLASTIC in 1 CARTON (41163-515-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

acetaminophen pm extra strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24b11c3b-9c19-ff00-e063-6394a90adbed", "openfda": {"upc": ["0041163488243"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["f86a11af-6d3c-4638-870d-a663ddf49371"], "manufacturer_name": ["United Natural Foods, Inc. dba UNFI"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (41163-515-01)  / 24 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "41163-515-01", "marketing_start_date": "20140901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (41163-515-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "41163-515-03", "marketing_start_date": "20140901"}], "brand_name": "acetaminophen pm extra strength", "product_id": "41163-515_24b11c3b-9c19-ff00-e063-6394a90adbed", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "41163-515", "generic_name": "Acetaminophen and Diphenhydramine Hydrochloride", "labeler_name": "United Natural Foods, Inc. dba UNFI", "product_type": "HUMAN OTC DRUG", "brand_name_base": "acetaminophen 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": "20140901", "listing_expiration_date": "20261231"}