equate ibuprofen pm

Product NDC
49035-699
11-digit product format
490350699
Labeler code
49035
Product ID
49035-699_d2f10efb-2d93-4050-83b6-ff227b5ef1da
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-04-15
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
equate 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
49035-699-27equate ibuprofen pm1 in 1 CARTONTABLET, FILM COATED15
49035-699-27equate ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED805
49035-699-60equate ibuprofen pm1 in 1 CARTONTABLET, FILM COATED15
49035-699-60equate ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-699EQUATE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC]5Current NDC, Legacy NDC, 4 package rows20250322_e36957ed-653c-465f-8150-7d6073e1376f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNe36957ed-653c-465f-8150-7d6073e1376f5
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDe36957ed-653c-465f-8150-7d6073e1376f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-699-27490350699271 BOTTLE in 1 CARTON (49035-699-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-04-150000-00-00NoNoCurrent
49035-699-60490350699601 BOTTLE in 1 CARTON (49035-699-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-04-150000-00-00NoNoCurrent