FDA.reportPublic FDA data

dg health Ibuprofen pm

Product NDC
55910-050
11-digit product format
559100050
Labeler code
55910
Product ID
55910-050_6eea1216-fa5d-4c82-a575-e382356d409d
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate and ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA079113
Marketing category
ANDA
Marketing start
2010-01-24
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
dg health 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
55910-050-27dg health Ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED808
55910-050-27dg health Ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18
55910-050-60dg health Ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED208
55910-050-60dg health Ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18
55910-050-65dg health Ibuprofen pm30 in 1 BOTTLETABLET, FILM COATED308
55910-050-65dg health Ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [DOLGENCORP INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-050DG HEALTH IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [DOLGENCORP INC]8Current NDC, Legacy NDC, 6 package rows20240125_4bbe40de-0957-4705-893d-fcb4191885c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN4bbe40de-0957-4705-893d-fcb4191885c98
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD4bbe40de-0957-4705-893d-fcb4191885c98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-050-27559100050271 BOTTLE in 1 CARTON (55910-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-03-190000-00-00NoNoCurrent
55910-050-60559100050601 BOTTLE in 1 CARTON (55910-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-01-240000-00-00NoNoCurrent
55910-050-655591000506530 in 1 BOTTLEHistorical