motrin dual action with tylenol

Generic: acetaminophen and ibuprofen

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

Drug Facts

Product Profile

Brand Name motrin dual action with tylenol
Generic Name acetaminophen and ibuprofen
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-208
Product ID 50580-208_48d075d6-52f3-6fd7-e063-6394a90ada71
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214836
Listing Expiration 2027-12-31
Marketing Start 2023-03-20

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 50580208
Hyphenated Format 50580-208

Supplemental Identifiers

RxCUI
2387532
UPC
0300450311207
UNII
362O9ITL9D 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 dual action with tylenol (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number ANDA214836 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-208-02) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-208-12) / 120 TABLET, FILM COATED in 1 BOTTLE
  • 2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (4)

50580-208-02 1 BOTTLE in 1 CARTON (50580-208-02) / 20 TABLET, FILM COATED in 1 BOTTLE 50580-208-08 1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLE 50580-208-12 1 BOTTLE in 1 CARTON (50580-208-12) / 120 TABLET, FILM COATED in 1 BOTTLE 50580-208-16 2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

Motrin Dual Action With Tylenol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48d075d6-52f3-6fd7-e063-6394a90ada71", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0300450311207"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["f2ee9cf5-02b7-6612-e053-2995a90a90c4"], "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 in 1 CARTON (50580-208-02)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-208-02", "marketing_start_date": "20230320"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-208-08)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-208-08", "marketing_start_date": "20230320"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-208-12)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-208-12", "marketing_start_date": "20230320"}, {"sample": false, "description": "2 CARTON in 1 CARTON (50580-208-16)  / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-208-16", "marketing_start_date": "20240401"}], "brand_name": "Motrin Dual Action With Tylenol", "product_id": "50580-208_48d075d6-52f3-6fd7-e063-6394a90ada71", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50580-208", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Motrin Dual Action With Tylenol", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA214836", "marketing_category": "ANDA", "marketing_start_date": "20230320", "listing_expiration_date": "20271231"}