FDA.reportPublic FDA data

Pain Relief Ibuprofen

Product NDC
11822-0292
11-digit product format
118220292
Labeler code
11822
Product ID
11822-0292_47aebcbb-409b-42ca-87a1-b4b1ecba214a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA075010
Marketing category
ANDA
Marketing start
1988-05-24
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
11822-0292-2Pain Relief Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
11822-0292-2Pain Relief Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10025
11822-0292-4Pain Relief Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50025
11822-0292-5Pain Relief Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
11822-0292-5Pain Relief Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5025
11822-0292-6Pain Relief Ibuprofen16 in 1 BOTTLE, PLASTICTABLET, FILM COATED1625
11822-0292-6Pain Relief Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
11822-0292-7Pain Relief Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
11822-0292-7Pain Relief Ibuprofen125 in 1 BOTTLE, PLASTICTABLET, FILM COATED12525
11822-0292-8Pain Relief Ibuprofen2 in 1 BLISTER PACKTABLET, FILM COATED225
11822-0292-8Pain Relief Ibuprofen1 in 1 BLISTER PACKTABLET, FILM COATED125

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
IBUPROFENACTIVE MOIETYWK2XYI10QMPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET [RITE AID]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0292PAIN RELIEF IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [RITE AID CORPORATION]24Current NDC, Legacy NDC, 11 package rows20250215_c85c3d1f-7639-4cfa-bf3a-424b61757b1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNc85c3d1f-7639-4cfa-bf3a-424b61757b1a25
310965ibuprofen 200 MG Oral TabletSCDc85c3d1f-7639-4cfa-bf3a-424b61757b1a25
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYc85c3d1f-7639-4cfa-bf3a-424b61757b1a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0292-2118220292021 BOTTLE, PLASTIC in 1 CARTON (11822-0292-2) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
11822-0292-411822029204500 TABLET, FILM COATED in 1 BOTTLE (11822-0292-4) 1988-05-240000-00-00NoNoCurrent
11822-0292-5118220292051 BOTTLE, PLASTIC in 1 CARTON (11822-0292-5) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
11822-0292-6118220292061 BOTTLE, PLASTIC in 1 CARTON (11822-0292-6) > 16 TABLET in 1 BOTTLE, PLASTIC1988-05-242021-10-08NoNoCurrent
11822-0292-7118220292071 BOTTLE, PLASTIC in 1 CARTON (11822-0292-7) > 125 TABLET in 1 BOTTLE, PLASTIC1988-05-242021-10-08NoNoCurrent
11822-0292-8118220292081 BLISTER PACK in 1 BLISTER PACK (11822-0292-8) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1988-05-242023-03-12NoNoCurrent