FDA.reportPublic FDA data

Ibuprofen

Product NDC
30142-660
11-digit product format
301420660
Labeler code
30142
Product ID
30142-660_93c0f168-3c04-43f0-875a-c4e9d20b044b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kroger Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
2002-11-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Brand name suffix
Childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
30142-660-26IbuprofenChildrens118 mL in 1 BOTTLESUSPENSION1188
30142-660-26IbuprofenChildrens1 in 1 CARTONSUSPENSION18
30142-660-28IbuprofenChildrens147 mL in 1 BOTTLESUSPENSION1478
30142-660-28IbuprofenChildrens1 in 1 CARTONSUSPENSION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30142-660-26ML - Milliliter30142-6606809da9b-ac92-4a7f-b13e-51bde08ab34512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-660IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]7Current NDC, Legacy NDC, 4 package rows20221105_47a3b118-614d-405d-b80e-31f0b354c430.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN47a3b118-614d-405d-b80e-31f0b354c4308
197803ibuprofen 20 MG/ML Oral SuspensionSCD47a3b118-614d-405d-b80e-31f0b354c4308
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY47a3b118-614d-405d-b80e-31f0b354c4308
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY47a3b118-614d-405d-b80e-31f0b354c4308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-660-26301420660261 BOTTLE in 1 CARTON (30142-660-26) / 118 mL in 1 BOTTLE1 bottle2002-11-200000-00-00NoNoCurrent
30142-660-28301420660281 BOTTLE in 1 CARTON (30142-660-28) > 147 mL in 1 BOTTLE1 bottle2012-12-080000-00-00NoNoCurrent