FDA.reportPublic FDA data

Childrens Ibuprofen

Product NDC
30142-965
11-digit product format
301420965
Labeler code
30142
Product ID
30142-965_39a7d0ad-faef-2f26-e063-6294a90ae0a3
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kroger Company
Application
ANDA209207
Marketing category
ANDA
Marketing start
2017-06-27
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
Childrens Ibuprofen
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-965-082023-02-01C16284748780-1f386c649-f6f7-0266-e053-dadaa90a7c1aChildren's Ibuprofen
30142-965-082023-01-30C16284748780-1f386c649-f6f7-0266-e053-dadaa90a7c1aChildren's Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-965-08Childrens Ibuprofen1 in 1 CARTONSUSPENSION15
30142-965-08Childrens Ibuprofen120 mL in 1 BOTTLESUSPENSION1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-965CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20241120_91da5b64-db7f-4954-89e8-977b31247f9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN91da5b64-db7f-4954-89e8-977b31247f9c5
197803ibuprofen 20 MG/ML Oral SuspensionSCD91da5b64-db7f-4954-89e8-977b31247f9c5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY91da5b64-db7f-4954-89e8-977b31247f9c5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY91da5b64-db7f-4954-89e8-977b31247f9c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-965-08301420965081 BOTTLE in 1 CARTON (30142-965-08) / 120 mL in 1 BOTTLE1 bottle2021-05-140000-00-00NoNoCurrent