FDA.reportPublic FDA data

Motrin IB

Product NDC
67751-120
11-digit product format
677510120
Labeler code
67751
Product ID
67751-120_f70c1b68-61c9-b333-e053-6294a90aadaa
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
NDA019012
Marketing category
NDA
Marketing start
2016-09-22
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui201126, 310965

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
67751-120-01Motrin IB2 in 1 POUCHTABLET, FILM COATED21
67751-120-01Motrin IB1 in 1 CARTONTABLET, FILM COATED11
67751-120-02Motrin IB2 in 1 CARTONTABLET, FILM COATED21
67751-120-02Motrin IB2 in 1 POUCHTABLET, FILM COATED21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-120MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]1Current NDC, 4 package rows20230317_f70c1b68-61c8-b333-e053-6294a90aadaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNf70c1b68-61c8-b333-e053-6294a90aadaa1
201126Motrin IB 200 MG Oral TabletPSNf70c1b68-61c8-b333-e053-6294a90aadaa1
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG Oral TabletSCDf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf70c1b68-61c8-b333-e053-6294a90aadaa1
201126Motrin 200 MG Oral TabletSYf70c1b68-61c8-b333-e053-6294a90aadaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67751-120-01677510120011 POUCH in 1 CARTON (67751-120-01) / 2 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-22NoNoCurrent
67751-120-02677510120022 POUCH in 1 CARTON (67751-120-02) / 2 TABLET, FILM COATED in 1 POUCH2 pouch2016-09-22NoNoCurrent