FDA.reportPublic FDA data

NDC 0573-0180-39 - ADVIL COLD AND SINUS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0573-0180
Requested NDC
0573-0180-39
Package NDCs from labels
0573-0180-39, 0573-0180-10, 0573-0180-21, 0573-0180-80
Manufacturer
Haleon US Holdings LLC
Effective date
2026-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ADVIL COLD AND SINUS - Haleon US Holdings LLCHaleon US Holdings LLC2026-02-02HUMAN OTC DRUG LABEL
ADVIL COLD AND SINUS - Haleon US Holdings LLCHaleon US Holdings LLC2025-06-13HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0180-102024-01-31C16284748780-11030e365-31c1-111a-e063-dadaa90a10e2Drug Facts
0573-0180-212024-01-31C16284748780-11030e365-31c1-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0180-10ADVIL COLD AND SINUS10 in 1 BLISTER PACKTABLET, COATED1016
0573-0180-10ADVIL COLD AND SINUS2 in 1 CARTONTABLET, COATED216
0573-0180-21ADVIL COLD AND SINUS10 in 1 BLISTER PACKTABLET, COATED1016
0573-0180-21ADVIL COLD AND SINUS4 in 1 CARTONTABLET, COATED416
0573-0180-80ADVIL COLD AND SINUS2 in 1 PACKAGETABLET, COATED216
0573-0180-80ADVIL COLD AND SINUS4 in 1 CARTONTABLET, COATED416
0573-0180-39ADVIL COLD AND SINUS2 in 1 POUCHTABLET, COATED21
0573-0180-39ADVIL COLD AND SINUS50 in 1 CARTONTABLET, COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0180ADVIL COLD AND SINUS (IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC]15Current NDC, Legacy NDC, 6 package rows20250511_fac22a47-f0de-4505-fd8a-768430cda0c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0180-10EA - Each0573-01804894699b-f98e-4132-a1d5-b7834976661812012-07-24
0573-0180-21EA - Each0573-0180d5744bb2-aee3-42fa-bfea-501ba674232b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ibuprofenACTIVE INGREDIENTWK2XYI10QMADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
pseudoephedrine hydrochlorideACTIVE INGREDIENT6V9V2RYJ8NADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
ibuprofenACTIVE MOIETYWK2XYI10QMADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
pseudoephedrineACTIVE MOIETY7CUC9DDI9FADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
SHELLACINACTIVE INGREDIENT46N107B71OADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
SUCROSEINACTIVE INGREDIENTC151H8M554ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]7

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 209 · 4,174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfef89d3f-16e1-4a76-aabd-11d6eca4be862026-09-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGobrands, Inc. (Goodnow)04e1b176-b74a-413e-a8e1-dd3764b9aa8b2026-09-01WarningsExact identifier
unii: WK2XYI10QM
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.4daddd32-615f-aedf-e063-6394a90a5b092026-09-01WarningsExact identifier
unii: 6V9V2RYJ8N
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: WK2XYI10QM
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: WK2XYI10QM
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Infants IbuprofenIBUPROFENWalgreens3bbbe142-a00c-404b-a116-81ad730ea1302026-08-25WarningsExact identifier
unii: WK2XYI10QM
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC26f2c3c1-a2f2-474a-950a-8cfe07f289fa2026-08-25WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.