FDA.reportPublic FDA data

good sense ibuprofen pm

Product NDC
0113-0050
11-digit product format
001130050
Labeler code
0113
Product ID
0113-0050_c80d2210-786d-4e91-ada6-f89caf3cf6d0
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-03-05
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
good sense 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0113-0050-27good sense ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED806
0113-0050-27good sense ibuprofen pm1 in 1 CARTONTABLET, FILM COATED16
0113-0050-58good sense ibuprofen pm1 in 1 CARTONTABLET, FILM COATED16
0113-0050-58good sense ibuprofen pm40 in 1 BOTTLETABLET, FILM COATED406
0113-0050-60good sense ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED206
0113-0050-60good sense ibuprofen pm1 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0050-58EA - Each0113-0050faa2a1fb-2098-42ab-8146-55ec802ab89412012-07-24
0113-0050-60EA - Each0113-00509265a050-ce86-4baa-b6be-7ffc49398d2012018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0050GOOD SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [L. PERRIGO COMPANY]6Current NDC, Legacy NDC, 6 package rows20250423_0488786f-9b6b-4935-bb57-bcb2565447f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN0488786f-9b6b-4935-bb57-bcb2565447f86
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD0488786f-9b6b-4935-bb57-bcb2565447f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0050-270011300502780 in 1 BOTTLEHistorical
0113-0050-58001130050581 BOTTLE in 1 CARTON (0113-0050-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-03-050000-00-00NoNoCurrent
0113-0050-60001130050601 BOTTLE in 1 CARTON (0113-0050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-05-070000-00-00NoNoCurrent