Dual Action

Product NDC
41226-716
11-digit product format
412260716
Labeler code
41226
Product ID
41226-716_002fdf94-eba4-9115-e063-6294a90a1582
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA216994
Marketing category
ANDA
Marketing start
2023-07-11
Substance
ACETAMINOPHEN; IBUPROFEN
Active strength
250; 125 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-716-49412260716491 BOTTLE in 1 CARTON (41226-716-49) / 144 TABLET in 1 BOTTLE1 bottle2023-07-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
716R Kroger 41226-716 Acetaminophen and Ibuprofen Tablets 250 mg/ 125 mgKROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED2023-07-12HUMAN OTC DRUG LABEL2