pain relief pm extra strength

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pain relief pm extra strength
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
TopCo Associates LLC

Identifiers & Regulatory

Product NDC 36800-095
Product ID 36800-095_3ff37f0e-3a25-dfd8-e063-6394a90ae3ca
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2012-11-30

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 36800095
Hyphenated Format 36800-095

Supplemental Identifiers

RxCUI
1092189
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 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 (36800-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 225 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-095-17)
source: ndc

Packages (2)

36800-095-03 1 BOTTLE, PLASTIC in 1 CARTON (36800-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 36800-095-17 225 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-095-17)

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": "3ff37f0e-3a25-dfd8-e063-6394a90ae3ca", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["3b672ec7-8658-4b43-a79d-094ac8bc6904"], "manufacturer_name": ["TopCo Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (36800-095-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-095-03", "marketing_start_date": "20121130"}, {"sample": false, "description": "225 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-095-17)", "package_ndc": "36800-095-17", "marketing_start_date": "20190321"}], "brand_name": "Pain Relief PM Extra Strength", "product_id": "36800-095_3ff37f0e-3a25-dfd8-e063-6394a90ae3ca", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-095", "generic_name": "Acetaminophen and Diphenhydramine Hydrochloride", "labeler_name": "TopCo Associates LLC", "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": "20121130", "listing_expiration_date": "20261231"}