pain relief pm extra strength

Generic: acetaminophen 500 mg and diphenhydramine hcl 25 mg

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pain relief pm extra strength
Generic Name acetaminophen 500 mg and diphenhydramine hcl 25 mg
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-393
Product ID 69168-393_d525d4d3-adac-40fb-a927-832f7d6a831b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2014-12-23

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 69168393
Hyphenated Format 69168-393

Supplemental Identifiers

RxCUI
1092189
UPC
0369168267992
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 pain relief pm extra strength (source: ndc)
Generic Name acetaminophen 500 mg and diphenhydramine hcl 25 mg (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 150 TABLET in 1 BOTTLE (69168-393-02)
  • 1 BOTTLE in 1 CARTON (69168-393-24) / 24 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69168-393-26) / 20 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69168-393-50) / 50 TABLET in 1 BOTTLE
  • 365 TABLET in 1 BOTTLE (69168-393-99)
source: ndc

Packages (5)

69168-393-02 150 TABLET in 1 BOTTLE (69168-393-02) 69168-393-24 1 BOTTLE in 1 CARTON (69168-393-24) / 24 TABLET in 1 BOTTLE 69168-393-26 1 BOTTLE in 1 CARTON (69168-393-26) / 20 TABLET in 1 BOTTLE 69168-393-50 1 BOTTLE in 1 CARTON (69168-393-50) / 50 TABLET in 1 BOTTLE 69168-393-99 365 TABLET in 1 BOTTLE (69168-393-99)

Ingredients (2)

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

Linked Drug Pages (1)

Pain Relief PM Extra Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d525d4d3-adac-40fb-a927-832f7d6a831b", "openfda": {"upc": ["0369168267992"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["423a8445-964c-4cdb-889a-f391ca5253e7"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 TABLET in 1 BOTTLE (69168-393-02)", "package_ndc": "69168-393-02", "marketing_start_date": "20141223"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-393-24)  / 24 TABLET in 1 BOTTLE", "package_ndc": "69168-393-24", "marketing_start_date": "20141223"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-393-26)  / 20 TABLET in 1 BOTTLE", "package_ndc": "69168-393-26", "marketing_start_date": "20211215"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-393-50)  / 50 TABLET in 1 BOTTLE", "package_ndc": "69168-393-50", "marketing_start_date": "20141223"}, {"sample": false, "description": "365 TABLET in 1 BOTTLE (69168-393-99)", "package_ndc": "69168-393-99", "marketing_start_date": "20141223"}], "brand_name": "Pain Relief PM Extra Strength", "product_id": "69168-393_d525d4d3-adac-40fb-a927-832f7d6a831b", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69168-393", "generic_name": "Acetaminophen 500 mg and Diphenhydramine HCl 25 mg", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pain Relief 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": "20141223", "listing_expiration_date": "20261231"}