ADVIL ALLERGY SINUS

Product NDC
0573-0188
11-digit product format
005730188
Labeler code
0573
Product ID
0573-0188_4db54932-2cdf-6aab-e063-6294a90af13f
Type
HUMAN OTC DRUG
Nonproprietary name
chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021441
Marketing category
NDA
Marketing start
2002-12-20
Substance
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2; 200; 30 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [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 ALLERGY SINUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/1
IBUPROFEN200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, WK2XYI10QM, 6V9V2RYJ8N
Rxcui1297390

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0188-102024-01-31C16284748780-10191ceaa-61f9-198a-e063-dbdaa90aec3eDrug Facts
0573-0188-102023-09-22C16284748780-10191ceaa-61f9-198a-e063-dbdaa90aec3eDrug Facts
0573-0188-102023-07-28C16284748780-10191ceaa-61f9-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0188-10ADVIL ALLERGY SINUS20 in 1 CARTONTABLET, COATED2018
0573-0188-10ADVIL ALLERGY SINUS1 in 1 BLISTER PACKTABLET, COATED118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0188-10EA - Each0573-018877b5d7f1-4aa1-4562-91a9-477975399fe912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2ADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0188ADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [HALEON US HOLDINGS LLC]17Current NDC, Legacy NDC, 2 package rows20240621_ecd6ea11-8b34-01b4-cbd9-901ba7a8f6e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297390chlorpheniramine maleate 2 MG / ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSNecd6ea11-8b34-01b4-cbd9-901ba7a8f6e218
1297390chlorpheniramine maleate 2 MG / ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCDecd6ea11-8b34-01b4-cbd9-901ba7a8f6e218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0188-100057301881020 BLISTER PACK in 1 CARTON (0573-0188-10) / 1 TABLET, COATED in 1 BLISTER PACK20 blister pack2002-12-200000-00-00NoNoCurrent