Advil

Manufacturer: Haleon US Holdings LLC
Effective date: 2025-10-03
Label type: HUMAN OTC DRUG LABEL
Version: 20
Source: full-release
Hydrated at: 2026-06-01 01:15:47

Label at a glance#

ProductAdvil

Active ingredientIBUPROFEN SODIUM

Label structure11 sections

Storage and handling

Other information each tablet contains: sodium 22 mg read all warnings and directions before use. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Contacts and useful links#

PhoneLabel contact1-800-88-ADVIL

Websitewww.advil.com

www.Advil.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/ Fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
temporarily reduces fever

WARNINGS SECTION

Warnings

Allergy alert:

SPL UNCLASSIFIED SECTION

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

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:

SPL UNCLASSIFIED SECTION

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

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

Heart attack and stroke warning

SPL UNCLASSIFIED SECTION

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

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

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, 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 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 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
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
the smallest effective dose should be used
adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 tablet, 2 tablets may be used
do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

Other information

each tablet contains: sodium 22 mg
read all warnings and directions before use.
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

Additional Information

SPL UNCLASSIFIED SECTION

Do Not Use if the sealed child resistant pouch is broken or torn.

For most recent product information, visit www.Advil.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Advil Tablets

Headache
Muscular Aches
Minor Pain of Arthritis
Menstrual Cramps
Toothache
Fever

See Full Drug Facts information on the back of this dispenser

100 TABLETS

(50 PACKETS of 2 TABLETS EACH)

000068427 Front Carton

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil ^®

20
FREE
TABLETS

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

Advil Tablets

100
Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
153008	Advil 200 MG Oral Tablet	PSN	20
310965	ibuprofen 200 MG Oral Tablet	PSN	20
153008	ibuprofen 200 MG Oral Tablet [Advil]	SBD	20
310965	ibuprofen 200 MG Oral Tablet	SCD	20
153008	Advil 200 MG Oral Tablet	SY	20
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	20

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0573-0133-01	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-02	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-04	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-05	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-20	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-40	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-41	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-80	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-81	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-88	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-89	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0133-91	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0134-20	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134
0573-0134-80	2024-01-31	C162847	48780-1	1030e365-3cba-111a-e063-dadaa90a10e2	Advil IBU Sodium NDC 0573-0133, 0573-0134

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-0133-01	Advil	2 in 1 PACKET	TABLET, COATED	2	20
0573-0133-01	Advil	3000 in 1 CASE	TABLET, COATED	3000	20
0573-0133-02	Advil	2 in 1 PACKET	TABLET, COATED	2	20
0573-0133-02	Advil	50 in 1 TRAY	TABLET, COATED	50	20
0573-0133-04	Advil	2 in 1 BLISTER PACK	TABLET, COATED	2	20
0573-0133-04	Advil	2 in 1 PACKET	TABLET, COATED	2	20
0573-0133-05	Advil	2 in 1 CARTON	TABLET, COATED	2	20
0573-0133-05	Advil	2 in 1 PACKET	TABLET, COATED	2	20
0573-0133-20	Advil	20 in 1 BOTTLE	TABLET, COATED	20	20
0573-0133-20	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0133-40	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0133-40	Advil	40 in 1 BOTTLE	TABLET, COATED	40	20
0573-0133-41	Advil	40 in 1 BOTTLE	TABLET, COATED	40	20
0573-0133-41	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0133-80	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0133-80	Advil	80 in 1 BOTTLE	TABLET, COATED	80	20
0573-0133-81	Advil	100 in 1 BOTTLE	TABLET, COATED	100	20
0573-0133-81	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0133-88	Advil	120 in 1 BOTTLE	TABLET, COATED	120	20
0573-0133-88	Advil	2 in 1 PACKAGE	TABLET, COATED	2	20
0573-0133-89	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0133-89	Advil	160 in 1 BOTTLE	TABLET, COATED	160	20
0573-0133-91	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0133-91	Advil	180 in 1 BOTTLE	TABLET, COATED	180	20
0573-0134-20	Advil	1 in 1 CARTON	TABLET, COATED	1	20
0573-0134-20	Advil	20 in 1 BOTTLE	TABLET, COATED	20	20
0573-0134-80	Advil	80 in 1 BOTTLE	TABLET, COATED	80	20
0573-0134-80	Advil	1 in 1 CARTON	TABLET, COATED	1	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-0133-05	EA - Each	0573-0133	17b8a8fd-9081-4699-81a0-61dc7ed5163d	1	2019-06-19
0573-0133-20	EA - Each	0573-0133	2dfaeb1d-708e-4b9f-bbec-e46f863f7247	1	2019-06-19
0573-0133-40	EA - Each	0573-0133	60bda876-b406-4188-bd44-f58fe62dc559	1	2019-06-19
0573-0133-80	EA - Each	0573-0133	cc5678ef-2794-42cc-8b4d-57a120005bb8	1	2015-12-02
0573-0134-20	EA - Each	0573-0134	52f8dbba-05c8-44cc-bcb9-b13a739732b8	1	2024-04-05
0573-0134-80	EA - Each	0573-0134	197e44be-693b-4b34-8839-0bdb4073ae88	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN SODIUM	ACTIVE INGREDIENT	RM1CE97Z4N	9
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	9
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	9
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	9
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	9
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	9
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	9
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	9

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Advil
ibuprofen sodium
ACESULFAME POTASSIUM
CARAMEL
CARNAUBA WAX
SILICON DIOXIDE
COPOVIDONE K25-31
FERRIC OXIDE RED
HYPROMELLOSE, UNSPECIFIED
MANNITOL
MEDIUM-CHAIN TRIGLYCERIDES
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
SUCRALOSE
TITANIUM DIOXIDE
IBUPROFEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0573-0133	0573-0133-20, 0573-0133-40, 0573-0133-80, 0573-0133-02, 0573-0133-04, 0573-0133-89, 0573-0133-81, 0573-0133-05, 0573-0133-88, 0573-0133-41, 0573-0133-91, 0573-0133-01
0573-0134	0573-0134-20, 0573-0134-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
CARAMEL	T9D99G2B1R	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
COPOVIDONE K25-31	D9C330MD8B	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MANNITOL	3OWL53L36A	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN SODIUM	RM1CE97Z4N	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
CARAMEL	T9D99G2B1R	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
COPOVIDONE K25-31	D9C330MD8B	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MANNITOL	3OWL53L36A	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN SODIUM	RM1CE97Z4N	ACTIB

Source Document#

Source XML · Source PDF

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 17 · 976 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 288 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	CAPSULE, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii+route 224 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	SUSPENSION / ORAL		172 mg	Exact identifier — unii+route 224 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii+route 112 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii+route 224 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii+route 112 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii+route 288 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TROCHE / ORAL		26 mg	Exact identifier — unii+route 208 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, EFFERVESCENT / ORAL		4 mg	Exact identifier — unii+route 208 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii+route 112 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii+route 112 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	PELLET / ORAL		1653 mg	Exact identifier — unii+route 224 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SOLUTION / ORAL		5566 mg	Exact identifier — unii+route 112 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii+route 112 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii+route 112 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, CHEWABLE / ORAL		15 mg	Exact identifier — unii+route 208 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 288 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	FILM, SOLUBLE / ORAL		10 mg	Exact identifier — unii+route 208 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii+route 112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii+route 112 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	TABLET, ORALLY DISINTEGRATING / ORAL		35 mg	Exact identifier — unii+route 224 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, CHEWABLE / ORAL		15 mg	Exact identifier — unii+route 208 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SUSPENSION / ORAL		10170 mg	Exact identifier — unii+route 112 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	FILM, SOLUBLE / ORAL		10 mg	Exact identifier — unii+route 208 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	TABLET, ORALLY DISINTEGRATING / ORAL		35 mg	Exact identifier — unii+route 224 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 288 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, FILM COATED / ORAL	1.75 mg		Exact identifier — unii+route 208 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii+route 112 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii+route 112 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TROCHE / ORAL		26 mg	Exact identifier — unii+route 208 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	TABLET, DELAYED RELEASE / ORAL		168 mg	Exact identifier — unii+route 224 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, ORALLY DISINTEGRATING / ORAL		24 mg	Exact identifier — unii+route 208 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	CAPSULE / ORAL		1346 mg	Exact identifier — unii+route 224 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SOLUTION / ORAL		5566 mg	Exact identifier — unii+route 112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SUSPENSION / ORAL		10170 mg	Exact identifier — unii+route 112 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TROCHE / ORAL		26 mg	Exact identifier — unii+route 208 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii+route 112 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SUSPENSION / ORAL		10170 mg	Exact identifier — unii+route 112 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii+route 112 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201803-001	ADVIL	IBUPROFEN SODIUM	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2012-06-12

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Advil	IBUPROFEN SODIUM	Haleon US Holdings LLC	5be198b8-396e-4b44-8819-e2e3b5d2ad0e	2025-10-03	Warnings	Exact identifier ndc (package): 0573-0133-91 ndc (package): 0573-0133-20 ndc (package): 0573-0133-88 ndc (package): 0573-0133-01 ndc (package): 0573-0133-04 ndc (package): 0573-0134-20 ndc (package): 0573-0133-81 ndc (package): 0573-0133-02 ndc (package): 0573-0133-80 ndc (package): 0573-0133-40 ndc (package): 0573-0133-41 ndc (package): 0573-0133-89 ndc (package): 0573-0134-80 ndc (package): 0573-0133-05 ndc (product): 0573-0133 ndc (product): 0573-0134 ndc11 (package): 00573013320 ndc11 (package): 00573013381 ndc11 (package): 00573013391 ndc11 (package): 00573013480 ndc11 (package): 00573013420 ndc11 (package): 00573013304 ndc11 (package): 00573013301 ndc11 (package): 00573013305 ndc11 (package): 00573013389 ndc11 (package): 00573013340 ndc11 (package): 00573013341 ndc11 (package): 00573013380 ndc11 (package): 00573013302 ndc11 (package): 00573013388 spl id: 40429ef4-846a-eb4c-e063-6394a90ab7a9 spl set id: 5be198b8-396e-4b44-8819-e2e3b5d2ad0e

Reported adverse events (FAERS/openFDA)#

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