ADVIL SINUS CONGESTION AND PAIN

Manufacturer
Haleon US Holdings LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:08:21

Label at a glance#

ProductADVIL SINUS CONGESTION AND PAIN
Active ingredientIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Storage and handling

Other information store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves these symptoms associated with the common cold or flu:
    • headache
    • fever
    • sinus pressure
    • nasal congestion
    • minor body aches and pains
  • reduces swelling of the nasal passages
  • temporarily restores freer breathing through the nose

WARNINGS SECTION

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

SPL UNCLASSIFIED SECTION

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

SPL UNCLASSIFIED SECTION

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

SPL UNCLASSIFIED SECTION

Heart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

  • in children under 12 years of age because this product contains too much medication for children under this age
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • taking any other product that contains phenylephrine or any other nasal decongestant
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • adults and children 12 years of age and over:
    • take 1 tablet every 4 hours while symptoms persist.
    • do not use more than 6 tablets in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use because this product contains too much medication for children under this age

STORAGE AND HANDLING SECTION

Other information

  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.

INACTIVE INGREDIENT SECTION

Inactive ingredients

acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

Call weekdays from 9 AM to 5 PM ESTtoll free at 1-800-88-ADVIL

Additional Information

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Product inside sealed in plastic blister with foil backing.
Do Not Use if plastic blister or foil barrier is broken.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information,

visit www.advil.com

Trademarks owned or licensed by GSK ©2021 GSK or licensor

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

NON-DROWSY

SINUS
CONGESTION & PAIN

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

  • Nasal Congestion
  • Headache
  • Sinus Pressure
  • Fever
  • Nasal Swelling
  • Body Aches

ONE
TABLET
DOSE!

1200-P10

30 Coated Tablets

000065893

Advil Sinus Congestion & Pain 30 Coated Tablets
Advil Sinus Congestion & Pain 30 Coated Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN15
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product 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

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
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ2
IBUPROFENACTIVE MOIETYWK2XYI10QM2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G92
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5AT2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9902
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V922
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD42
TALCINACTIVE INGREDIENT7SEV7J4R1U2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TRIACETININACTIVE INGREDIENTXHX3C3X6732
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-01990573-0199-11, 0573-0199-21, 0573-0199-01, 0573-0199-22, 0573-0199-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 504 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVTABLET / ORAL48 mgExact identifier — unii+route
6 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii+route
78 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route
78 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii+route
42 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
108 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
108 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
108 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
108 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii+route
114 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii+route
114 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
108 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
108 equally ranked IID candidates
EGG PHOSPHOLIPIDSEGG PHOSPHOLIPIDS1Z74184RGVTABLET / ORAL48 mgExact identifier — unii+route
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
108 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route
18 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
108 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii+route
114 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
108 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
108 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FILM COATED / ORAL1.75 mgExact identifier — unii+route
78 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
108 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
108 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
108 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii+route
114 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii+route
42 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii+route
114 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
108 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
108 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii+route
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
114 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii+route
114 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii+route
114 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
108 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route
78 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
36 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii+route
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii+route
114 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATCAPSULE / ORAL132 mgExact identifier — unii+route
24 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii+route
78 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022565-001ADVIL CONGESTION RELIEFIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORALRLD, RS2010-05-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2784e616aacf4f…
2026-08-18 06:07:402026-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273f01610625f2…
2019-09-15 20:21 UTC2019-09N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27f41ea6bd6efb…

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL SINUS CONGESTION AND PAINIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf2025-07-22WarningsExact identifier
ndc (package): 0573-0199-01
ndc (package): 0573-0199-03
ndc (package): 0573-0199-22
ndc (package): 0573-0199-21
ndc (package): 0573-0199-11
ndc (product): 0573-0199
ndc11 (package): 00573019901
ndc11 (package): 00573019921
ndc11 (package): 00573019922
ndc11 (package): 00573019911
ndc11 (package): 00573019903
spl id: 3a894971-32f7-0c16-e063-6294a90aa8d9
spl set id: b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf

Reported adverse events (FAERS/openFDA)#

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