FDA.reportPublic FDA data

Ibuprofen PM

Product NDC
41250-050
11-digit product format
412500050
Labeler code
41250
Product ID
41250-050_182350eb-e5cb-4c58-bbec-aaee7e38d5c4
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-04-08
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
Ibuprofen PM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE CITRATE38 mg/1
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4OD433S209, WK2XYI10QM
Rxcui895664

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-050-20Ibuprofen PM20 in 1 BOTTLETABLET, FILM COATED207
41250-050-27Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17
41250-050-27Ibuprofen PM80 in 1 BOTTLETABLET, FILM COATED807
41250-050-48Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17
41250-050-48Ibuprofen PM180 in 1 BOTTLETABLET, FILM COATED1807
41250-050-58Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17
41250-050-58Ibuprofen PM40 in 1 BOTTLETABLET, FILM COATED407
41250-050-60Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17
41250-050-76Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17
41250-050-76Ibuprofen PM120 in 1 BOTTLETABLET, FILM COATED1207

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-050IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]5Current NDC, Legacy NDC, 10 package rows20240308_47e71e23-da8a-4759-ac5a-1d48e0d9ab98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN47e71e23-da8a-4759-ac5a-1d48e0d9ab987
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD47e71e23-da8a-4759-ac5a-1d48e0d9ab987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-050-204125000502020 in 1 BOTTLEHistorical
41250-050-27412500050271 BOTTLE in 1 CARTON (41250-050-27) > 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-04-080000-00-00NoNoCurrent
41250-050-48412500050481 in 1 CARTONHistorical
41250-050-58412500050581 BOTTLE in 1 CARTON (41250-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-04-080000-00-00NoNoCurrent
41250-050-60412500050601 BOTTLE in 1 CARTON (41250-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE (41250-050-20) 1 bottle2026-03-05NoNoHistorical
41250-050-76412500050761 BOTTLE in 1 CARTON (41250-050-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-10-210000-00-00NoNoCurrent