advil pm

Generic: diphenhydramine citrate and ibuprofen

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name advil pm
Generic Name diphenhydramine citrate and ibuprofen
Labeler haleon us holdings llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0164
Product ID 0573-0164_15971707-84cd-4742-e063-6394a90af906
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021394
Listing Expiration 2026-12-31
Marketing Start 2005-12-21

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 05730164
Hyphenated Format 0573-0164

Supplemental Identifiers

RxCUI
895664
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 advil pm (source: ndc)
Generic Name diphenhydramine citrate and ibuprofen (source: ndc)
Application Number NDA021394 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 4 TABLET, COATED in 1 POUCH (0573-0164-04)
  • 2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE
  • 1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL
  • 8 TABLET, COATED in 1 VIAL (0573-0164-09)
  • 6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH
  • 2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH
  • 1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE
  • 50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH
  • 120 TABLET, COATED in 1 BOTTLE (0573-0164-65)
  • 3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH
source: ndc

Packages (21)

0573-0164-04 4 TABLET, COATED in 1 POUCH (0573-0164-04) 0573-0164-05 2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE 0573-0164-08 1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL 0573-0164-09 8 TABLET, COATED in 1 VIAL (0573-0164-09) 0573-0164-12 6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH 0573-0164-14 2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH 0573-0164-20 1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE 0573-0164-21 1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE 0573-0164-30 1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE 0573-0164-32 1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE 0573-0164-33 1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE 0573-0164-40 1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE 0573-0164-41 1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE 0573-0164-43 1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE 0573-0164-44 1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE 0573-0164-45 1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE 0573-0164-46 1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE 0573-0164-49 1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE 0573-0164-55 50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH 0573-0164-65 120 TABLET, COATED in 1 BOTTLE (0573-0164-65) 0573-0164-91 3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH

Ingredients (2)

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

Linked Drug Pages (1)

ADVIL PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "15971707-84cd-4742-e063-6394a90af906", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["658fc201-47c9-6a6d-8af9-6208298d43b4"], "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": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, COATED in 1 POUCH (0573-0164-04)", "package_ndc": "0573-0164-04", "marketing_start_date": "20051221"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (0573-0164-05)  / 2 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-05", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 VIAL in 1 PACKAGE (0573-0164-08)  / 8 TABLET, COATED in 1 VIAL", "package_ndc": "0573-0164-08", "marketing_start_date": "20170317"}, {"sample": false, "description": "8 TABLET, COATED in 1 VIAL (0573-0164-09)", "package_ndc": "0573-0164-09", "marketing_start_date": "20170317"}, {"sample": false, "description": "6 POUCH in 1 CARTON (0573-0164-12)  / 2 TABLET, COATED in 1 POUCH", "package_ndc": "0573-0164-12", "marketing_start_date": "20051221"}, {"sample": false, "description": "2 POUCH in 1 CARTON (0573-0164-14)  / 2 TABLET, COATED in 1 POUCH", "package_ndc": "0573-0164-14", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-20)  / 20 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-20", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-21)  / 30 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-21", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-30)  / 40 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-30", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-32)  / 50 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-32", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-33)  / 50 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-33", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-40)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-40", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-41)  / 100 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-41", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-43)  / 120 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-43", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-44)  / 140 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-44", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-45)  / 180 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-45", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-46)  / 180 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-46", "marketing_start_date": "20051221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0164-49)  / 200 TABLET, COATED in 1 BOTTLE", "package_ndc": "0573-0164-49", "marketing_start_date": "20051221"}, {"sample": false, "description": "50 POUCH in 1 TRAY (0573-0164-55)  / 2 TABLET, COATED in 1 POUCH", "package_ndc": "0573-0164-55", "marketing_start_date": "20051221"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (0573-0164-65)", "package_ndc": "0573-0164-65", "marketing_start_date": "20160930"}, {"sample": false, "description": "3000 POUCH in 1 BOX (0573-0164-91)  / 2 TABLET, COATED in 1 POUCH", "package_ndc": "0573-0164-91", "marketing_start_date": "20051221"}], "brand_name": "ADVIL PM", "product_id": "0573-0164_15971707-84cd-4742-e063-6394a90af906", "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": "0573-0164", "generic_name": "diphenhydramine citrate and ibuprofen", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADVIL PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "NDA021394", "marketing_category": "NDA", "marketing_start_date": "20051221", "listing_expiration_date": "20261231"}