FDA.reportPublic FDA data

Motrin IB Migraine

Product NDC
50580-120
11-digit product format
505800120
Labeler code
50580
Product ID
50580-120_460cceff-0b2e-cbfe-e063-6394a90aa46f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
ANDA078682
Marketing category
ANDA
Marketing start
2021-01-18
Substance
IBUPROFEN
Active strength
200 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
Motrin IB Migraine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964, 606990

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
50580-120-20Motrin IB Migraine20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED204
50580-120-20Motrin IB Migraine1 in 1 CARTONCAPSULE, LIQUID FILLED14
50580-120-80Motrin IB Migraine80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED804
50580-120-80Motrin IB Migraine1 in 1 CARTONCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-120MOTRIN IB MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]3Current NDC, Legacy NDC, 4 package rows20241122_34818110-5291-4bda-9571-bd77d90bba7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN34818110-5291-4bda-9571-bd77d90bba7c4
606990Motrin IB 200 MG Oral CapsulePSN34818110-5291-4bda-9571-bd77d90bba7c4
606990ibuprofen 200 MG Oral Capsule [Motrin]SBD34818110-5291-4bda-9571-bd77d90bba7c4
310964ibuprofen 200 MG Oral CapsuleSCD34818110-5291-4bda-9571-bd77d90bba7c4
606990Motrin 200 MG Oral CapsuleSY34818110-5291-4bda-9571-bd77d90bba7c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50580-120-20505800120201 BOTTLE, PLASTIC in 1 CARTON (50580-120-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-01-180000-00-00NoNoCurrent
50580-120-80505800120801 BOTTLE, PLASTIC in 1 CARTON (50580-120-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-01-180000-00-00NoNoCurrent