FDA.reportPublic FDA data

Advil PM

Product NDC
67751-147
11-digit product format
677510147
Labeler code
67751
Product ID
67751-147_4efb3fed-e69e-91c7-e063-6294a90aafdd
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE CITRATE, IBUPROFEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
NDA021394
Marketing category
NDA
Marketing start
2016-09-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Advil PM
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-147-012023-01-30C16284748780-1f386c649-d953-0266-e053-dadaa90a7c1aAdvil PM
67751-147-022023-01-30C16284748780-1f386c649-d953-0266-e053-dadaa90a7c1aAdvil PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-147-01Advil PM1 in 1 CARTONTABLET, COATED13
67751-147-01Advil PM2 in 1 POUCHTABLET, COATED23
67751-147-02Advil PM4 in 1 POUCHTABLET, COATED43
67751-147-02Advil PM2 in 1 CARTONTABLET, COATED23
67751-147-06Advil PM2 in 1 POUCHTABLET, COATED23
67751-147-06Advil PM3 in 1 CARTONTABLET, COATED33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-147ADVIL PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, Legacy NDC, 6 package rows20191206_a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNa3c30dd2-75f3-4f8b-88d7-4a63dea5bad73
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDa3c30dd2-75f3-4f8b-88d7-4a63dea5bad73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-147-01677510147011 POUCH in 1 CARTON (67751-147-01) / 2 TABLET, COATED in 1 POUCH1 pouch2016-09-160000-00-00NoNoCurrent
67751-147-02677510147022 POUCH in 1 CARTON (67751-147-02) / 4 TABLET, COATED in 1 POUCH2 pouch2016-09-160000-00-00NoNoCurrent
67751-147-06677510147063 POUCH in 1 CARTON (67751-147-06) / 2 TABLET, COATED in 1 POUCH3 pouch2025-04-25NoNoCurrent