FDA.reportPublic FDA data

Childrens Ibuprofen

Product NDC
11822-0166
11-digit product format
118220166
Labeler code
11822
Product ID
11822-0166_a9ada71c-d6ae-405d-b575-fb0bc4f70c00
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA074937
Marketing category
ANDA
Marketing start
2002-05-10
Marketing end
2026-12-31
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

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
11822-0166-1Childrens Ibuprofen1 in 1 CARTONSUSPENSION18
11822-0166-1Childrens Ibuprofen150 mL in 1 BOTTLESUSPENSION1508
11822-0166-3Childrens Ibuprofen240 mL in 1 BOTTLESUSPENSION2408
11822-0166-3Childrens Ibuprofen1 in 1 CARTONSUSPENSION18
11822-0166-4Childrens Ibuprofen1 in 1 CARTONSUSPENSION18
11822-0166-4Childrens Ibuprofen120 mL in 1 BOTTLESUSPENSION1208

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
IBUPROFENACTIVE MOIETYWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0166CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]7Current NDC, Legacy NDC, 6 package rows20250112_1da544eb-ed4e-4124-bea3-f827f1322270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN1da544eb-ed4e-4124-bea3-f827f13222708
197803ibuprofen 20 MG/ML Oral SuspensionSCD1da544eb-ed4e-4124-bea3-f827f13222708
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY1da544eb-ed4e-4124-bea3-f827f13222708
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY1da544eb-ed4e-4124-bea3-f827f13222708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0166-1118220166011 BOTTLE in 1 CARTON (11822-0166-1) > 150 mL in 1 BOTTLE1 bottle2015-07-230000-00-00NoNoCurrent
11822-0166-3118220166031 BOTTLE in 1 CARTON (11822-0166-3) / 240 mL in 1 BOTTLE1 bottle2008-05-080000-00-00NoNoCurrent
11822-0166-4118220166041 BOTTLE in 1 CARTON (11822-0166-4) / 120 mL in 1 BOTTLE1 bottle2002-05-100000-00-00NoNoCurrent