FDA.reportPublic FDA data

ibuprofen

Product NDC
30142-897
11-digit product format
301420897
Labeler code
30142
Product ID
30142-897_1b6a5d2f-b6b5-4220-a26b-659595180bdf
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kroger Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
1999-01-19
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
30142-897-26ibuprofenchildrens1 in 1 CARTONSUSPENSION19
30142-897-26ibuprofenchildrens118 mL in 1 BOTTLESUSPENSION1189
30142-897-28ibuprofenchildrens1 in 1 CARTONSUSPENSION19
30142-897-28ibuprofenchildrens147 mL in 1 BOTTLESUSPENSION1479
30142-897-34ibuprofenchildrens240 mL in 1 BOTTLESUSPENSION2409
30142-897-34ibuprofenchildrens1 in 1 CARTONSUSPENSION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30142-897-26ML - Milliliter30142-897e5da5553-413f-4dbf-ad19-c0558587427912014-07-02
30142-897-34ML - Milliliter30142-897f7d1bbdb-f5bc-4da9-8de3-902e5c94905412015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-897IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [KROGER COMPANY]9Current NDC, Legacy NDC, 6 package rows20221105_7b84c5bd-334d-402f-a93b-d11196b5a130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN7b84c5bd-334d-402f-a93b-d11196b5a1309
197803ibuprofen 20 MG/ML Oral SuspensionSCD7b84c5bd-334d-402f-a93b-d11196b5a1309
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY7b84c5bd-334d-402f-a93b-d11196b5a1309
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY7b84c5bd-334d-402f-a93b-d11196b5a1309

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-897-26301420897261 BOTTLE in 1 CARTON (30142-897-26) > 118 mL in 1 BOTTLE1 bottle1999-01-210000-00-00NoNoCurrent
30142-897-28301420897281 BOTTLE in 1 CARTON (30142-897-28) > 147 mL in 1 BOTTLE1 bottle2013-09-040000-00-00NoNoCurrent
30142-897-34301420897341 BOTTLE in 1 CARTON (30142-897-34) / 240 mL in 1 BOTTLE1 bottle2004-05-100000-00-00NoNoCurrent