FDA.reportPublic FDA data

Rexall Ibuprofen

Product NDC
55910-685
11-digit product format
559100685
Labeler code
55910
Product ID
55910-685_e623eadd-a3af-4781-812c-3f88893131f2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA074937
Marketing category
ANDA
Marketing start
2010-08-19
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
Rexall Ibuprofen
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
55910-685-26Rexall Ibuprofen1 in 1 CARTONSUSPENSION15
55910-685-26Rexall Ibuprofen118 mL in 1 BOTTLESUSPENSION1185

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
WATERINACTIVE INGREDIENT059QF0KO0RREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEREXALL IBUPROFEN (IBUPROFEN) LIQUID [DOLGENCORP INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-685REXALL IBUPROFEN (IBUPROFEN) SUSPENSION [DOLGENCORP, LLC]5Current NDC, Legacy NDC, 2 package rows20230619_d2dc2f71-c0cb-4e6d-85b9-fcf386e207a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNd2dc2f71-c0cb-4e6d-85b9-fcf386e207a05
197803ibuprofen 20 MG/ML Oral SuspensionSCDd2dc2f71-c0cb-4e6d-85b9-fcf386e207a05
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYd2dc2f71-c0cb-4e6d-85b9-fcf386e207a05
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYd2dc2f71-c0cb-4e6d-85b9-fcf386e207a05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-685-26559100685261 BOTTLE in 1 CARTON (55910-685-26) / 118 mL in 1 BOTTLE1 bottle2010-08-190000-00-00NoNoCurrent