Dual Action

Product NDC
21130-716
11-digit product format
211300716
Labeler code
21130
Product ID
21130-716_20402a78-3dea-b88c-e063-6294a90ab75a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
BETTER LIVING BRANDS, LLC
Application
ANDA216994
Marketing category
ANDA
Marketing start
2023-08-30
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
21130-716-08211300716081 BOTTLE in 1 CARTON (21130-716-08) / 18 TABLET in 1 BOTTLE1 bottle2023-08-30NoNoHistorical
21130-716-75211300716751 BOTTLE in 1 CARTON (21130-716-75) / 72 TABLET in 1 BOTTLE1 bottle2023-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
716R Albertsons 21130-716 Acetaminophen and Ibuprofen Tablets 250 mg/ 125 mgBETTER LIVING BRANDS, LLC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED2024-08-22HUMAN OTC DRUG LABEL4