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

Additional Listing Data#

Finished product
Yes
Brand name base
Dual Action
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
IBUPROFEN125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2387532

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-716-49Dual Action144 in 1 BOTTLETABLET1442
41226-716-49Dual Action1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-716DUAL ACTION (ACETAMINOPHEN, IBUPROFEN) TABLET [KROGER COMPANY]2Current NDC, 2 package rows20230712_ee0ae5e6-388d-0085-e053-2a95a90add8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNee0ae5e6-388d-0085-e053-2a95a90add8e2
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDee0ae5e6-388d-0085-e053-2a95a90add8e2
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYee0ae5e6-388d-0085-e053-2a95a90add8e2

Packages#

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