motrin pm

Generic: ibuprofen and diphenhydramine citrate

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name motrin pm
Generic Name ibuprofen and diphenhydramine citrate
Labeler kenvue brands llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

diphenhydramine citrate 38 mg/1, ibuprofen 200 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-563
Product ID 50580-563_39a34ab2-9fae-444e-e063-6294a90a9152
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079113
Listing Expiration 2026-12-31
Marketing Start 2010-01-11

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580563
Hyphenated Format 50580-563

Supplemental Identifiers

RxCUI
895664 895666
UPC
0300450563804
UNII
4OD433S209 WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 motrin pm (source: ndc)
Generic Name ibuprofen and diphenhydramine citrate (source: ndc)
Application Number ANDA079113 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

50580-563-20 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC 50580-563-80 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (2)

diphenhydramine citrate (38 mg/1) ibuprofen (200 mg/1)

Linked Drug Pages (1)

Motrin PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39a34ab2-9fae-444e-e063-6294a90a9152", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0300450563804"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664", "895666"], "spl_set_id": ["55403f19-58ae-450b-8a7b-0bc544088f20"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20)  / 20 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-563-20", "marketing_start_date": "20100111"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80)  / 80 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-563-80", "marketing_start_date": "20100111"}], "brand_name": "Motrin PM", "product_id": "50580-563_39a34ab2-9fae-444e-e063-6294a90a9152", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50580-563", "generic_name": "Ibuprofen and Diphenhydramine Citrate", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Motrin", "brand_name_suffix": "PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079113", "marketing_category": "ANDA", "marketing_start_date": "20100111", "listing_expiration_date": "20261231"}