FDA.reportPublic FDA data

ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated

Product NDC
29485-6533
11-digit product format
294856533
Labeler code
29485
Product ID
29485-6533_2a83226d-0fe9-8955-e063-6394a90a5bfc
Type
HUMAN OTC DRUG
Nonproprietary name
Advil PM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil Drug Store Products, Inc
Application
NDA021394
Marketing category
NDA
Marketing start
2017-08-25
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
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated
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
29485-6533-4ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated2 in 1 POUCHTABLET, COATED25
29485-6533-4ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated2 in 1 CARTONTABLET, COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-6533ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC]5Current NDC, 2 package rows20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNd1138e15-8ae4-7b49-e053-2995a90a96075
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDd1138e15-8ae4-7b49-e053-2995a90a96075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
29485-6533-4294856533042 POUCH in 1 CARTON (29485-6533-4) / 2 TABLET, COATED in 1 POUCH2 pouch2017-08-25NoNoHistorical