FDA.reportPublic FDA data

Childrens Ibuprofen

Product NDC
68094-503
11-digit product format
680940503
Labeler code
68094
Product ID
68094-503_569c23f2-55ee-4921-80ca-9362c8ce58b6
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA074937
Marketing category
ANDA
Marketing start
2006-09-14
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-503-59Childrens Ibuprofen10 mL in 1 CUP, UNIT-DOSESUSPENSION105
68094-503-61Childrens Ibuprofen10 in 1 CASESUSPENSION105
68094-503-61Childrens Ibuprofen10 in 1 TRAYSUSPENSION105
68094-503-62Childrens Ibuprofen3 in 1 CASESUSPENSION35
68094-503-62Childrens Ibuprofen10 in 1 TRAYSUSPENSION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-503-59ML - Milliliter68094-5037686d365-f568-49b3-a6e7-76b30dfdd0c312012-07-24
68094-503-61ML - Milliliter68094-503a421cc2c-3207-4256-9196-b4c59a63211412012-07-24
68094-503-62ML - Milliliter68094-50333e14671-0323-4a30-88c2-308e9e9295be12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-503CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]4Current NDC, Legacy NDC, 5 package rows20250110_59b881f9-1830-4bce-99d2-9770c9b2575f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN59b881f9-1830-4bce-99d2-9770c9b2575f5
197803ibuprofen 20 MG/ML Oral SuspensionSCD59b881f9-1830-4bce-99d2-9770c9b2575f5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY59b881f9-1830-4bce-99d2-9770c9b2575f5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY59b881f9-1830-4bce-99d2-9770c9b2575f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-503-596809405035910 mL in 1 CUP, UNIT-DOSE10 mlHistorical
68094-503-616809405036110 TRAY in 1 CASE (68094-503-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59) 10 tray2006-09-140000-00-00NoNoCurrent
68094-503-62680940503623 TRAY in 1 CASE (68094-503-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59) 3 tray2006-09-140000-00-00NoNoCurrent