FDA.reportPublic FDA data

basic care ibuprofen pm

Product NDC
72288-050
11-digit product format
722880050
Labeler code
72288
Product ID
72288-050_4ba6a10c-51df-435f-8df6-b9e43f696eec
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA079113
Marketing category
ANDA
Marketing start
2021-04-30
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
basic care 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
72288-050-60basic care ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED204
72288-050-60basic care ibuprofen pm1 in 1 CARTONTABLET, FILM COATED14
72288-050-76basic care ibuprofen pm120 in 1 BOTTLETABLET, FILM COATED1204
72288-050-76basic care ibuprofen pm1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-050BASIC CARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]4Current NDC, Legacy NDC, 4 package rows20241001_6bd8bad2-4370-4450-822a-9ef50949a8fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN6bd8bad2-4370-4450-822a-9ef50949a8fc4
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD6bd8bad2-4370-4450-822a-9ef50949a8fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-050-60722880050601 BOTTLE in 1 CARTON (72288-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-100000-00-00NoNoCurrent
72288-050-76722880050761 BOTTLE in 1 CARTON (72288-050-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-300000-00-00NoNoCurrent