Advil PM, CVP HEALTH

Product NDC
66715-6533
11-digit product format
667156533
Labeler code
66715
Product ID
66715-6533_27e68e85-e284-30b9-e063-6394a90aba9b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Diphenhydramine citrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA021394
Marketing category
NDA
Marketing start
2022-05-06
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38; 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
4OD433S209DIPHENHYDRAMINE CITRATE88637-37-0DIPHENHYDRAMINE CITRATE
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-6533-2667156533022 POUCH in 1 CARTON (66715-6533-2) / 2 TABLET, COATED in 1 POUCH2 pouch2022-05-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Advil ® PM Lil' Drug Store ® , TRAVEL BASIX, CVP ® HEALTHLil' Drug Store Products, Inc.2024-11-27HUMAN OTC DRUG LABEL12