equaline ibuprofen pm

Product NDC
41163-050
11-digit product format
411630050
Labeler code
41163
Product ID
41163-050_d06f41f5-6ade-4964-a941-d8fc41a39529
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-03-02
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
equaline 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
41163-050-27equaline ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED807
41163-050-27equaline ibuprofen pm1 in 1 CARTONTABLET, FILM COATED17
41163-050-58equaline ibuprofen pm40 in 1 BOTTLETABLET, FILM COATED407
41163-050-58equaline ibuprofen pm1 in 1 CARTONTABLET, FILM COATED17
41163-050-60equaline ibuprofen pm1 in 1 CARTONTABLET, FILM COATED17
41163-050-60equaline ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED207

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
IBUPROFENACTIVE INGREDIENTWK2XYI10QMEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
IBUPROFENACTIVE MOIETYWK2XYI10QMEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SUPERVALU INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-050EQUALINE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]7Current NDC, Legacy NDC, 6 package rows20250423_5c4ff82a-bdc4-4df5-9df7-abc6becf4f4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN5c4ff82a-bdc4-4df5-9df7-abc6becf4f4d7
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD5c4ff82a-bdc4-4df5-9df7-abc6becf4f4d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-050-27411630050271 BOTTLE in 1 CARTON (41163-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-03-020000-00-00NoNoCurrent
41163-050-58411630050581 BOTTLE in 1 CARTON (41163-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-03-210000-00-00NoNoCurrent
41163-050-60411630050601 BOTTLE in 1 CARTON (41163-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2012-01-110000-00-00NoNoCurrent