ADVIL PM

Product NDC
0573-0148
11-digit product format
005730148
Labeler code
0573
Product ID
0573-0148_7ff3116f-dc72-460c-ac1a-80753f1aeb55
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine HCl, ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021393
Marketing category
NDA
Marketing start
2025-01-15
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength
25; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
TC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE147-24-0DIPHENHYDRAMINE HYDROCHLORIDE
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0573-0148-06005730148061 BOTTLE in 1 CARTON (0573-0148-06) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-01-15NoNoHistorical
0573-0148-07005730148071 BOTTLE in 1 CARTON (0573-0148-07) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-01-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsHaleon US Holdings LLC2025-01-15HUMAN OTC DRUG LABEL21