FDA.reportPublic FDA data

Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg

Product NDC
63548-0197
11-digit product format
635480197
Labeler code
63548
Product ID
63548-0197_fbc47d79-348d-436e-ae3f-364d76f58e49
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen, Diphenhydramine Citrate
Dosage form
TABLET
Route
ORAL
Labeler
PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application
ANDA211404
Marketing category
ANDA
Marketing start
2024-04-11
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
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg
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
63548-0197-2Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg1 in 1 BOXTABLET16
63548-0197-2Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg20 in 1 BOTTLE, PLASTICTABLET206
63548-0197-3Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg300 in 1 BOTTLE, PLASTICTABLET3006
63548-0197-8Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg8 in 1 BOTTLE, PLASTICTABLET86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-0197IBUPROFEN 200 MG AND DIPHENHYDRAMINE CITRATE 38 MG (IBUPROFEN, DIPHENHYDRAMINE CITRATE) TABLET [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]6Current NDC, 4 package rows20240426_a7d729bf-6d7a-415a-a414-cae0ba6d0063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNa7d729bf-6d7a-415a-a414-cae0ba6d00636
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDa7d729bf-6d7a-415a-a414-cae0ba6d00636

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63548-0197-2635480197021 BOTTLE, PLASTIC in 1 BOX (63548-0197-2) / 20 TABLET in 1 BOTTLE, PLASTIC2024-04-11NoNoHistorical
63548-0197-363548019703300 TABLET in 1 BOTTLE, PLASTIC (63548-0197-3) 300 tablet2024-04-11NoNoHistorical
63548-0197-8635480197088 TABLET in 1 BOTTLE, PLASTIC (63548-0197-8) 8 tablet2024-04-11NoNoHistorical