acetaminophen pm extra strength

Generic: acetaminophen, diphenhydramine hcl

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen pm extra strength
Generic Name acetaminophen, diphenhydramine hcl
Labeler sam's west inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-556
Product ID 68196-556_5cd8d2b6-f250-4b0f-a377-ef1ec3e52d43
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2007-12-17

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 68196556
Hyphenated Format 68196-556

Supplemental Identifiers

RxCUI
1092189
UPC
0078742095851
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, diphenhydramine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 375 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-556-54)
source: ndc

Packages (1)

68196-556-54 375 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-556-54)

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": "5cd8d2b6-f250-4b0f-a377-ef1ec3e52d43", "openfda": {"upc": ["0078742095851"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["cff9a730-2241-4e4c-bf6b-a2fa895e2417"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "375 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-556-54)", "package_ndc": "68196-556-54", "marketing_start_date": "20071217"}], "brand_name": "acetaminophen pm extra strength", "product_id": "68196-556_5cd8d2b6-f250-4b0f-a377-ef1ec3e52d43", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68196-556", "generic_name": "acetaminophen, diphenhydramine HCl", "labeler_name": "Sam's West Inc", "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": "20071217", "listing_expiration_date": "20261231"}