FDA.reportPublic FDA data

CHILDRENS Ibuprofen

Product NDC
81033-019
11-digit product format
810330019
Labeler code
81033
Product ID
81033-019_436c00d4-44ed-b9a9-e063-6294a90a9448
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA074937
Marketing category
ANDA
Marketing start
2011-04-28
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
2027-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
81033-019-01CHILDRENS Ibuprofen100 in 1 CASESUSPENSION1001
81033-019-02CHILDRENS Ibuprofen100 in 1 CASESUSPENSION1001
81033-019-05CHILDRENS Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION51
81033-019-10CHILDRENS Ibuprofen10 mL in 1 CUP, UNIT-DOSESUSPENSION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-019-01ML - Milliliter81033-019a604c420-3580-406e-a5d9-fb47f6e68de312026-05-22
81033-019-02ML - Milliliter81033-01981eb0f56-8fbc-438e-a712-38033096859612026-05-22
81033-019-05ML - Milliliter81033-019ef7052d0-20a5-4520-9b08-417c8ec5601e12026-05-22
81033-019-10ML - Milliliter81033-019e9232af5-cddf-49d8-88a2-99414fba6e1012026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN436c0126-4ff3-c082-e063-6294a90a3d722
197803ibuprofen 20 MG/ML Oral SuspensionSCD436c0126-4ff3-c082-e063-6294a90a3d722
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY436c0126-4ff3-c082-e063-6294a90a3d722
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY436c0126-4ff3-c082-e063-6294a90a3d722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-019-0181033001901100 CUP, UNIT-DOSE in 1 CASE (81033-019-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-019-05) 2025-11-01NoNoCurrent
81033-019-0281033001902100 CUP, UNIT-DOSE in 1 CASE (81033-019-02) / 10 mL in 1 CUP, UNIT-DOSE (81033-019-10) 2025-11-01NoNoCurrent
81033-019-05810330019055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-019-108103300191010 mL in 1 CUP, UNIT-DOSE10 mlHistorical