FDA.reportPublic FDA data

Advil Sinus Congestion and Pain

Product NDC
52904-782
11-digit product format
529040782
Labeler code
52904
Product ID
52904-782_bf8fc6fa-d880-4cd1-a815-1d3ad3cd955e
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen, phenylephrine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Select Corporation
Application
NDA022565
Marketing category
NDA
Marketing start
2015-07-01
Marketing end
0000-00-00
Substance
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
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
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-782-032024-01-30C16284748780-11030e365-2e0f-111a-e063-dadaa90a10e2Advil ® Sinus Congestion & Pain
52904-782-042024-01-30C16284748780-11030e365-2e0f-111a-e063-dadaa90a10e2Advil ® Sinus Congestion & Pain
52904-782-252024-01-30C16284748780-11030e365-2e0f-111a-e063-dadaa90a10e2Advil ® Sinus Congestion & Pain
52904-782-502024-01-30C16284748780-11030e365-2e0f-111a-e063-dadaa90a10e2Advil ® Sinus Congestion & Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-782-03Advil Sinus Congestion and Pain1 in 1 BLISTER PACKTABLET, COATED12
52904-782-03Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-04Advil Sinus Congestion and Pain2 in 1 BLISTER PACKTABLET, COATED22
52904-782-04Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-25Advil Sinus Congestion and Pain25 in 1 CARTONTABLET, COATED252
52904-782-25Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-50Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-50Advil Sinus Congestion and Pain50 in 1 CARTONTABLET, COATED502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-782ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SELECT CORPORATION]2Legacy NDC, 8 package rows20220414_dc7ebdf5-52f1-4341-a2cb-c96fa6272dd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSNdc7ebdf5-52f1-4341-a2cb-c96fa6272dd92
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDdc7ebdf5-52f1-4341-a2cb-c96fa6272dd92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-782-03529040782031 POUCH in 1 BLISTER PACK (52904-782-03) > 1 TABLET, COATED in 1 POUCH1 pouch2015-07-010000-00-00NoNoCurrent
52904-782-04529040782042 POUCH in 1 BLISTER PACK (52904-782-04) > 1 TABLET, COATED in 1 POUCH2 pouch2015-07-010000-00-00NoNoCurrent
52904-782-255290407822525 POUCH in 1 CARTON (52904-782-25) > 1 TABLET, COATED in 1 POUCH25 pouch2015-07-010000-00-00NoNoCurrent
52904-782-505290407825050 POUCH in 1 CARTON (52904-782-50) > 1 TABLET, COATED in 1 POUCH50 pouch2015-07-010000-00-00NoNoCurrent