FDA.reportPublic FDA data

pain relief ibuprofen

Product NDC
11822-0392
11-digit product format
118220392
Labeler code
11822
Product ID
11822-0392_6aeec91f-0e6c-42a6-9858-6a5619557ea6
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA075139
Marketing category
ANDA
Marketing start
2002-03-30
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
pain relief ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
11822-0392-2pain relief ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10029
11822-0392-2pain relief ibuprofen1 in 1 CARTONTABLET, FILM COATED129
11822-0392-4pain relief ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50029
11822-0392-5pain relief ibuprofen1 in 1 CARTONTABLET, FILM COATED129
11822-0392-5pain relief ibuprofen50 in 1 BOTTLETABLET, FILM COATED5029

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
IBUPROFENACTIVE MOIETYWK2XYI10QMPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0392PAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID CORPORATION]28Current NDC, Legacy NDC, 5 package rows20250221_2bd1438e-27b1-81ff-f8e1-0f5b50b04581.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN2bd1438e-27b1-81ff-f8e1-0f5b50b0458129
310965ibuprofen 200 MG Oral TabletSCD2bd1438e-27b1-81ff-f8e1-0f5b50b0458129
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2bd1438e-27b1-81ff-f8e1-0f5b50b0458129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0392-2118220392021 BOTTLE, PLASTIC in 1 CARTON (11822-0392-2) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2002-03-300000-00-00NoNoCurrent
11822-0392-411822039204500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-0392-4) 2002-03-300000-00-00NoNoCurrent
11822-0392-5118220392051 BOTTLE in 1 CARTON (11822-0392-5) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2002-03-300000-00-00NoNoCurrent