FDA.reportPublic FDA data

Motrin Dual Action With Tylenol

Product NDC
50580-208
11-digit product format
505800208
Labeler code
50580
Product ID
50580-208_48d075d6-52f3-6fd7-e063-6394a90ada71
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
ANDA214836
Marketing category
ANDA
Marketing start
2023-03-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Motrin Dual Action With Tylenol
Listing expiration
2027-12-31

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
50580-208-02Motrin Dual Action With Tylenol1 in 1 CARTONTABLET, FILM COATED17
50580-208-02Motrin Dual Action With Tylenol20 in 1 BOTTLETABLET, FILM COATED207
50580-208-08Motrin Dual Action With Tylenol80 in 1 BOTTLETABLET, FILM COATED807
50580-208-08Motrin Dual Action With Tylenol1 in 1 CARTONTABLET, FILM COATED17
50580-208-12Motrin Dual Action With Tylenol1 in 1 CARTONTABLET, FILM COATED17
50580-208-12Motrin Dual Action With Tylenol120 in 1 BOTTLETABLET, FILM COATED1207
50580-208-16Motrin Dual Action With Tylenol2 in 1 CARTONTABLET, FILM COATED27
50580-208-16Motrin Dual Action With Tylenol1 in 1 CARTONTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-208-08EA - Each50580-2080544a36e-8d2a-4a70-862a-ce961202330112024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-208MOTRIN DUAL ACTION WITH TYLENOL (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [KENVUE BRANDS LLC]6Current NDC, 8 package rows20250315_f2ee9cf5-02b7-6612-e053-2995a90a90c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNf2ee9cf5-02b7-6612-e053-2995a90a90c47
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDf2ee9cf5-02b7-6612-e053-2995a90a90c47
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYf2ee9cf5-02b7-6612-e053-2995a90a90c47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50580-208-02505800208021 BOTTLE in 1 CARTON (50580-208-02) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-03-20NoNoHistorical
50580-208-08505800208081 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-03-20NoNoHistorical
50580-208-12505800208121 BOTTLE in 1 CARTON (50580-208-12) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-03-20NoNoHistorical
50580-208-16505800208162 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE2 carton2024-04-01NoNoHistorical