Ibuprofen PM

Product NDC
69842-870
11-digit product format
698420870
Labeler code
69842
Product ID
69842-870_f0d4869d-7769-7121-e053-2995a90a562e
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN, DIPHENHYDRAMINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA090397
Marketing category
ANDA
Marketing start
2021-10-19
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 formatDescriptionMarketing startSampleExclude flagStatus
69842-870-15698420870151 BOTTLE, PLASTIC in 1 CARTON (69842-870-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-10-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CVS Ibuprofen PM capsulesCVS Pharmacy | Bionpharma Inc. | Patheon Softgels Inc.2022-12-27HUMAN OTC DRUG LABEL3