FDA.reportPublic FDA data

Dye Free Childrens Ibuprofen

Product NDC
0121-1022
11-digit product format
001211022
Labeler code
0121
Product ID
0121-1022_d1635350-9966-4795-9bc2-6cf2b690eaec
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA210602
Marketing category
ANDA
Marketing start
2023-11-03
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
Dye Free 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
0121-1022-00Dye Free Childrens Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION511
0121-1022-00Dye Free Childrens Ibuprofen10 in 1 CASESUSPENSION1011
0121-1022-05Dye Free Childrens Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION511
0121-1022-05Dye Free Childrens Ibuprofen10 in 1 TRAYSUSPENSION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1022-00ML - Milliliter0121-1022617a8c34-bf42-43c5-8ece-3babf1df40ad12024-05-16
0121-1022-05ML - Milliliter0121-1022c1a7b17a-8fc5-4d8a-b685-09b35eb6499f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1022DYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]11Current NDC, 4 package rows20250205_a616a7cd-4814-478e-8c58-7fbc2454d992.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNa616a7cd-4814-478e-8c58-7fbc2454d99211
197803ibuprofen 20 MG/ML Oral SuspensionSCDa616a7cd-4814-478e-8c58-7fbc2454d99211
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYa616a7cd-4814-478e-8c58-7fbc2454d99211
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYa616a7cd-4814-478e-8c58-7fbc2454d99211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0121-1022-000012110220010 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE2023-11-03NoNoHistorical
0121-1022-050012110220510 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE2023-11-03NoNoHistorical