foster and thrive ibuprofen pm

Product NDC
70677-1131
11-digit product format
706771131
Labeler code
70677
Product ID
70677-1131_8691e397-e598-4e23-a389-2dbbb8f4496a
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA079113
Marketing category
ANDA
Marketing start
2023-11-01
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
70677-1131-1706771131011 BOTTLE in 1 CARTON (70677-1131-1) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
McKesson Ibuprofen PM Drug FactsStrategic Sourcing Services LLC2023-11-01HUMAN OTC DRUG LABEL1