FDA.reportPublic FDA data

Childrens Ibuprofen Oral Suspension, Dye Free

Product NDC
63941-128
11-digit product format
639410128
Labeler code
63941
Product ID
63941-128_1f314365-45d0-40c1-806b-7a3c6ea7d283
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Best Choice
Application
ANDA210602
Marketing category
ANDA
Marketing start
2025-01-01
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 Oral Suspension, Dye Free
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
63941-128-24Childrens Ibuprofen Oral Suspension, Dye Free118 mL in 1 BOTTLESUSPENSION1181
63941-128-24Childrens Ibuprofen Oral Suspension, Dye Free1 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-128CHILDRENS IBUPROFEN ORAL SUSPENSION, DYE FREE (IBUPROFEN) SUSPENSION [BEST CHOICE]1Current NDC, 2 package rows20250129_55fd05c7-b902-4c82-ab9a-8054d880dfbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN55fd05c7-b902-4c82-ab9a-8054d880dfbd1
197803ibuprofen 20 MG/ML Oral SuspensionSCD55fd05c7-b902-4c82-ab9a-8054d880dfbd1
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY55fd05c7-b902-4c82-ab9a-8054d880dfbd1
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY55fd05c7-b902-4c82-ab9a-8054d880dfbd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63941-128-24639410128241 BOTTLE in 1 CARTON (63941-128-24) / 118 mL in 1 BOTTLE1 bottle2025-01-01NoNoHistorical