FDA.reportPublic FDA data

Care One Ibuprofen PM

Product NDC
41520-050
11-digit product format
415200050
Labeler code
41520
Product ID
41520-050_af71245d-9e26-4aaf-b061-3b2dc519572c
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate and ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Sales Company
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-02-20
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
Care One 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
41520-050-27Care One Ibuprofen PM80 in 1 BOTTLETABLET, FILM COATED8011
41520-050-27Care One Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED111
41520-050-48Care One Ibuprofen PM180 in 1 BOTTLETABLET, FILM COATED18011
41520-050-48Care One Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED111
41520-050-58Care One Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED111
41520-050-58Care One Ibuprofen PM40 in 1 BOTTLETABLET, FILM COATED4011
41520-050-60Care One Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED111
41520-050-60Care One Ibuprofen PM20 in 1 BOTTLETABLET, FILM COATED2011
41520-050-76Care One Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED111
41520-050-76Care One Ibuprofen PM120 in 1 BOTTLETABLET, FILM COATED12011
41520-050-82Care One Ibuprofen PM200 in 1 BOTTLETABLET, FILM COATED20011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
IBUPROFENACTIVE MOIETYWK2XYI10QMCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
TALCINACTIVE INGREDIENT7SEV7J4R1UCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-050CARE ONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [AMERICAN SALES COMPANY]10Current NDC, Legacy NDC, 11 package rows20250423_d5bf76d1-6fed-4f6b-8507-3e8973295d67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNd5bf76d1-6fed-4f6b-8507-3e8973295d6711
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDd5bf76d1-6fed-4f6b-8507-3e8973295d6711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-050-27415200050271 BOTTLE in 1 CARTON (41520-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-200000-00-00NoNoCurrent
41520-050-48415200050481 BOTTLE in 1 CARTON (41520-050-48) > 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-03-060000-00-00NoNoCurrent
41520-050-58415200050581 BOTTLE in 1 CARTON (41520-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-200000-00-00NoNoCurrent
41520-050-60415200050601 BOTTLE in 1 CARTON (41520-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-200000-00-00NoNoCurrent
41520-050-76415200050761 in 1 CARTONHistorical
41520-050-8241520005082200 TABLET, FILM COATED in 1 BOTTLE (41520-050-82) 2017-09-050000-00-00NoNoCurrent