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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074937-001CHILDREN'S IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS IbuprofenIBUPROFENKesin Pharma Corporation436c0126-4ff3-c082-e063-6294a90a3d722026-04-13WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor’s care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts mo...

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