FDA.reportPublic FDA data

Ibuprofen

Product NDC
30142-685
11-digit product format
301420685
Labeler code
30142
Product ID
30142-685_a61cdbde-ceb5-4a1b-9b7a-1d632e7f3811
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kroger Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
2011-04-25
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-685-262024-01-30C16284748780-11030e364-fc38-111a-e063-dadaa90a10e2Kroger Co. Children’s Ibuprofen Drug Facts
30142-685-282024-01-30C16284748780-11030e364-fc38-111a-e063-dadaa90a10e2Kroger Co. Children’s Ibuprofen Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-685-26Ibuprofen118 mL in 1 BOTTLESUSPENSION1187
30142-685-26Ibuprofen1 in 1 CARTONSUSPENSION17
30142-685-28Ibuprofen147 mL in 1 BOTTLESUSPENSION1477
30142-685-28Ibuprofen1 in 1 CARTONSUSPENSION17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [KROGER COMPANY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [KROGER COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [KROGER COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [KROGER COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN SUSPENSION [KROGER COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [KROGER COMPANY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [KROGER COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [KROGER COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [KROGER COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [KROGER COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [KROGER COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-685IBUPROFEN SUSPENSION [KROGER COMPANY]7Legacy NDC, 4 package rows20221105_804582e1-730f-4d14-91db-2a9f6287b8a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN804582e1-730f-4d14-91db-2a9f6287b8a07
197803ibuprofen 20 MG/ML Oral SuspensionSCD804582e1-730f-4d14-91db-2a9f6287b8a07
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY804582e1-730f-4d14-91db-2a9f6287b8a07
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY804582e1-730f-4d14-91db-2a9f6287b8a07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-685-26301420685261 BOTTLE in 1 CARTON (30142-685-26) > 118 mL in 1 BOTTLE1 bottle2011-04-252022-11-30NoNoCurrent
30142-685-28301420685281 BOTTLE in 1 CARTON (30142-685-28) > 147 mL in 1 BOTTLE1 bottle2012-12-080000-00-00NoNoCurrent