FDA.reportPublic FDA data

ibuprofen pm

Product NDC
59779-050
11-digit product format
597790050
Labeler code
59779
Product ID
59779-050_606dc577-e485-4e35-afd0-41373c9cb627
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate and ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-02-17
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
59779-050-27ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED8011
59779-050-27ibuprofen pm1 in 1 CARTONTABLET, FILM COATED111
59779-050-33ibuprofen pm1 in 1 CARTONTABLET, FILM COATED111
59779-050-33ibuprofen pm60 in 1 BOTTLETABLET, FILM COATED6011
59779-050-48ibuprofen pm180 in 1 BOTTLETABLET, FILM COATED18011
59779-050-48ibuprofen pm1 in 1 CARTONTABLET, FILM COATED111
59779-050-58ibuprofen pm1 in 1 CARTONTABLET, FILM COATED111
59779-050-58ibuprofen pm40 in 1 BOTTLETABLET, FILM COATED4011
59779-050-60ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED2011
59779-050-60ibuprofen pm1 in 1 CARTONTABLET, FILM COATED111
59779-050-65ibuprofen pm30 in 1 BOTTLETABLET, FILM COATED3011
59779-050-65ibuprofen pm1 in 1 CARTONTABLET, FILM COATED111
59779-050-76ibuprofen pm1 in 1 CARTONTABLET, FILM COATED111
59779-050-76ibuprofen pm120 in 1 BOTTLETABLET, FILM COATED12011
59779-050-82ibuprofen pm200 in 1 BOTTLETABLET, FILM COATED20011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-050-27EA - Each59779-050e698c95f-895e-4f34-af06-815b6514030a12012-07-24
59779-050-48EA - Each59779-050ad5f6c49-5dc2-41fb-9d77-6112c834420c12022-06-06
59779-050-58EA - Each59779-050493a3285-aec6-406f-8267-3749361411ef12022-06-06
59779-050-60EA - Each59779-0504d700f0b-59be-4ca7-b13a-8b1d21a0555612017-11-06
59779-050-76EA - Each59779-050c23bdf4d-48b1-4a9d-91c6-c8a20bd3f81b12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [CVS PHARMACY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-050IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [CVS PHARMACY]10Current NDC, Legacy NDC, 15 package rows20230922_44e4e54b-cb40-4b7c-a141-181bde62a69f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN44e4e54b-cb40-4b7c-a141-181bde62a69f11
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD44e4e54b-cb40-4b7c-a141-181bde62a69f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-050-27597790050271 BOTTLE in 1 CARTON (59779-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-170000-00-00NoNoCurrent
59779-050-33597790050331 in 1 CARTONHistorical
59779-050-4859779005048180 in 1 BOTTLEHistorical
59779-050-58597790050581 in 1 CARTONHistorical
59779-050-60597790050601 BOTTLE in 1 CARTON (59779-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-05-010000-00-00NoNoCurrent
59779-050-65597790050651 BOTTLE in 1 CARTON (59779-050-65) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-170000-00-00NoNoCurrent
59779-050-76597790050761 BOTTLE in 1 CARTON (59779-050-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-04-270000-00-00NoNoCurrent
59779-050-8259779005082200 TABLET, FILM COATED in 1 BOTTLE (59779-050-82) 2017-09-120000-00-00NoNoCurrent