FDA.reportPublic FDA data

ibuprofen

Product NDC
11822-0255
11-digit product format
118220255
Labeler code
11822
Product ID
11822-0255_506650be-6e84-4ce5-aae0-dc2aacd488b4
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA075217
Marketing category
ANDA
Marketing start
2005-06-03
Marketing end
2026-11-01
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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
ibuprofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442

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
11822-0255-1ibuprofen1 in 1 CARTONSUSPENSION/ DROPS110
11822-0255-1ibuprofen30 mL in 1 BOTTLESUSPENSION/ DROPS3010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION/ DROPS [RITE AID CORPORATION]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION/ DROPS [RITE AID CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0255IBUPROFEN SUSPENSION/ DROPS [RITE AID CORPORATION]9Current NDC, Legacy NDC, 2 package rows20240304_99a76de3-166a-4902-b400-b262a4fa0ae8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSN99a76de3-166a-4902-b400-b262a4fa0ae810
204442ibuprofen 40 MG/ML Oral SuspensionSCD99a76de3-166a-4902-b400-b262a4fa0ae810
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSY99a76de3-166a-4902-b400-b262a4fa0ae810
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSY99a76de3-166a-4902-b400-b262a4fa0ae810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0255-1118220255011 BOTTLE in 1 CARTON (11822-0255-1) / 30 mL in 1 BOTTLE1 bottle2005-06-030000-00-00NoNoCurrent