FDA.reportPublic FDA data

Ibuprofen PM

Product NDC
0363-0050
11-digit product format
003630050
Labeler code
0363
Product ID
0363-0050_2e8f3546-0aa7-4f2d-a201-037e01bae76a
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-02-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen PM
Listing expiration
2026-12-31

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
0363-0050-27Ibuprofen PM80 in 1 BOTTLETABLET, FILM COATED8010
0363-0050-27Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED110
0363-0050-48Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED110
0363-0050-48Ibuprofen PM180 in 1 BOTTLETABLET, FILM COATED18010
0363-0050-58Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED110
0363-0050-58Ibuprofen PM40 in 1 BOTTLETABLET, FILM COATED4010
0363-0050-60Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED110
0363-0050-60Ibuprofen PM20 in 1 BOTTLETABLET, FILM COATED2010
0363-0050-76Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED110
0363-0050-76Ibuprofen PM120 in 1 BOTTLETABLET, FILM COATED12010
0363-0050-82Ibuprofen PM200 in 1 BOTTLETABLET, FILM COATED20010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0050-27EA - Each0363-0050ca47cf7e-f3bf-49e5-9b2d-eb5a22a366b012022-06-06
0363-0050-60EA - Each0363-0050714f2a28-14a9-42b6-9887-1f77c3370cc912022-06-06
0363-0050-76EA - Each0363-00500fea71ea-bd44-479c-a29a-485509c5638812022-06-06
0363-0050-82EA - Each0363-00502aa45090-689c-4b98-92ea-367e9ec3c89012022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WALGREEN COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0050IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY]9Current NDC, Legacy NDC, 11 package rows20241114_9c5c1f48-d285-4faa-96d0-b04f435c9c5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN9c5c1f48-d285-4faa-96d0-b04f435c9c5c10
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD9c5c1f48-d285-4faa-96d0-b04f435c9c5c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0050-27003630050271 BOTTLE in 1 CARTON (0363-0050-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-190000-00-00NoNoCurrent
0363-0050-48003630050481 in 1 CARTONHistorical
0363-0050-58003630050581 BOTTLE in 1 CARTON (0363-0050-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-07-120000-00-00NoNoCurrent
0363-0050-60003630050601 BOTTLE in 1 CARTON (0363-0050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-190000-00-00NoNoCurrent
0363-0050-76003630050761 BOTTLE in 1 CARTON (0363-0050-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-01-070000-00-00NoNoCurrent
0363-0050-8200363005082200 TABLET, FILM COATED in 1 BOTTLE (0363-0050-82) 2017-09-210000-00-00NoNoCurrent