FDA.reportPublic FDA data

ADVIL SINUS CONGESTION AND PAIN

Product NDC
0573-0199
11-digit product format
005730199
Labeler code
0573
Product ID
0573-0199_3a894971-32f7-0c16-e063-6294a90aa8d9
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen, phenylephrine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA022565
Marketing category
NDA
Marketing start
2015-07-01
Substance
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200; 10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ADVIL SINUS CONGESTION AND PAIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM, 04JA59TNSJ
Rxcui1369775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0199-012024-01-31C16284748780-11030e365-1c23-111a-e063-dadaa90a10e2Drug Facts
0573-0199-032024-01-31C16284748780-11030e365-1c23-111a-e063-dadaa90a10e2Drug Facts
0573-0199-112024-01-31C16284748780-11030e365-1c23-111a-e063-dadaa90a10e2Drug Facts
0573-0199-212024-01-31C16284748780-11030e365-1c23-111a-e063-dadaa90a10e2Drug Facts
0573-0199-222024-01-31C16284748780-11030e365-1c23-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0199-01ADVIL SINUS CONGESTION AND PAIN50 in 1 TRAYTABLET, COATED5015
0573-0199-01ADVIL SINUS CONGESTION AND PAIN1 in 1 POUCHTABLET, COATED115
0573-0199-03ADVIL SINUS CONGESTION AND PAIN1 in 1 POUCHTABLET, COATED115
0573-0199-03ADVIL SINUS CONGESTION AND PAIN3000 in 1 CARTONTABLET, COATED300015
0573-0199-11ADVIL SINUS CONGESTION AND PAIN10 in 1 CARTONTABLET, COATED1015
0573-0199-11ADVIL SINUS CONGESTION AND PAIN1 in 1 BLISTER PACKTABLET, COATED115
0573-0199-21ADVIL SINUS CONGESTION AND PAIN1 in 1 BLISTER PACKTABLET, COATED115
0573-0199-21ADVIL SINUS CONGESTION AND PAIN20 in 1 CARTONTABLET, COATED2015
0573-0199-22ADVIL SINUS CONGESTION AND PAIN30 in 1 CARTONTABLET, COATED3015
0573-0199-22ADVIL SINUS CONGESTION AND PAIN1 in 1 BLISTER PACKTABLET, COATED115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0199-01EA - Each0573-0199fe6b0032-049b-4318-b7e7-4644ce1a56bb12022-06-06
0573-0199-11EA - Each0573-0199d09ca4e4-e359-4c8b-8e56-2eb0999773dd12019-06-19
0573-0199-21EA - Each0573-01997c6ed005-4992-481e-9ed0-12a03d86a84612023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
TALCINACTIVE INGREDIENT7SEV7J4R1UADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0199ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 10 package rows20250316_b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSNb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf15
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf15
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN531abadc-37fd-4953-95bc-a211a2ba69143
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD531abadc-37fd-4953-95bc-a211a2ba69143
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
0573-0199-010057301990150 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCH50 pouch2015-07-010000-00-00NoNoCurrent
0573-0199-03005730199033000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCH3000 pouch2015-07-010000-00-00NoNoCurrent
0573-0199-110057301991110 BLISTER PACK in 1 CARTON (0573-0199-11) / 1 TABLET, COATED in 1 BLISTER PACK10 blister pack2015-07-010000-00-00NoNoCurrent
0573-0199-210057301992120 BLISTER PACK in 1 CARTON (0573-0199-21) / 1 TABLET, COATED in 1 BLISTER PACK20 blister pack2015-07-010000-00-00NoNoCurrent
0573-0199-220057301992230 BLISTER PACK in 1 CARTON (0573-0199-22) / 1 TABLET, COATED in 1 BLISTER PACK30 blister pack2015-11-020000-00-00NoNoCurrent