FDA.reportPublic FDA data

ADVIL COLD AND SINUS

Product NDC
0573-2160
11-digit product format
005732160
Labeler code
0573
Product ID
0573-2160_cec76100-19bc-49c3-8805-7badb2a8bf28
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen and pseudoephedrine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA019771
Marketing category
NDA
Marketing start
2018-01-01
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200; 30 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-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 COLD AND SINUS
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM, 6V9V2RYJ8N
Rxcui1299021

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
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2160-74ADVIL COLD AND SINUS4 in 1 CARTONTABLET, COATED416
0573-2160-74ADVIL COLD AND SINUS2 in 1 PACKAGETABLET, COATED216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2160-74EA - Each0573-216085c8c543-ad93-481f-84b8-924cab1adff812025-10-14

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSNfac22a47-f0de-4505-fd8a-768430cda0c116
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCDfac22a47-f0de-4505-fd8a-768430cda0c116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0573-2160-74005732160742 CARTON in 1 PACKAGE (0573-2160-74) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK2 carton2018-01-01NoNoCurrent