advil pm

Generic: diphenhydramine hcl, 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 hcl, ibuprofen
Labeler haleon us holdings llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1, ibuprofen 200 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0148
Product ID 0573-0148_7ff3116f-dc72-460c-ac1a-80753f1aeb55
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021393
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

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 05730148
Hyphenated Format 0573-0148

Supplemental Identifiers

RxCUI
901814
UNII
WK2XYI10QM TC2D6JAD40
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 hcl, ibuprofen (source: ndc)
Application Number NDA021393 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0573-0148-06) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0148-07) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (2)

0573-0148-06 1 BOTTLE in 1 CARTON (0573-0148-06) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 0573-0148-07 1 BOTTLE in 1 CARTON (0573-0148-07) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (2)

diphenhydramine hydrochloride (25 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": "7ff3116f-dc72-460c-ac1a-80753f1aeb55", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "TC2D6JAD40"], "rxcui": ["901814"], "spl_set_id": ["405afdb4-c157-1d88-f232-848063ba4714"], "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": "1 BOTTLE in 1 CARTON (0573-0148-06)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "0573-0148-06", "marketing_start_date": "20250115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0148-07)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "0573-0148-07", "marketing_start_date": "20250115"}], "brand_name": "ADVIL PM", "product_id": "0573-0148_7ff3116f-dc72-460c-ac1a-80753f1aeb55", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "0573-0148", "generic_name": "diphenhydramine HCl, ibuprofen", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADVIL PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "NDA021393", "marketing_category": "NDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}