Advil ® Tablets

Manufacturer: Lil' Drug Store Products, Inc.
Effective date: 2025-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 00:53:55

Label at a glance#

ProductAdvil

Active ingredientIBUPROFEN

Label structure14 sections

Indications and 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

Dosage and administration

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

read all warnings and directions before use. Keep carton. 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID) ¹

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-800-88-ADVIL

SPL UNCLASSIFIED SECTION

Repackaged and distributed with permission of Pfizer Consumer Healthcare by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

Lil' Drug Store Advil - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil ^®

Ibuprofen Tablets, 200 mg
Pain Reliever / Fever Reducer (NSAID)

[tablet image]

Coated
Tablets

Lil' Drug Store ^®

PDP

Travel BASIX Advil - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200 mg
Pain Reliever / Fever Reducer (NSAID)

[tablet image]

Tablets

Coated

Tablets

[Travel BASIX logo]

PDP/Package

CVP Health Advil - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200 mg
Pain Reliever / Fever Reducer (NSAID)

[tablet image]

Tablets

Coated

Tablets

[CVP _® Health logo]

PDP/Package

Advil 30pc Dispens-It Box, Lil' Drug Store ®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[tablet image]

Tablets

Headache
Mainor Pain of Arthritis
Toothache
Muscular Aches
Menstrual Cramps
Fever

See full Drug Facys information

on the back of this dispenser

60 TABLETS

(30 PACKETS OF 2 COATED TABLETS EACH)

[Lil' Drug Store ^® logo]

PDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
153008	Advil 200 MG Oral Tablet	PSN	12
310965	ibuprofen 200 MG Oral Tablet	PSN	12
153008	ibuprofen 200 MG Oral Tablet [Advil]	SBD	12
310965	ibuprofen 200 MG Oral Tablet	SCD	12
153008	Advil 200 MG Oral Tablet	SY	12
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	12

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
66715-6434-2	2024-01-30	C162847	48780-1	1030e365-08c4-111a-e063-dadaa90a10e2	Advil ® Tablets
66715-6500-2	2024-01-30	C162847	48780-1	1030e365-08c4-111a-e063-dadaa90a10e2	Advil ® Tablets
66715-9700-1	2024-01-30	C162847	48780-1	1030e365-08c4-111a-e063-dadaa90a10e2	Advil ® Tablets
66715-9700-2	2024-01-30	C162847	48780-1	1030e365-08c4-111a-e063-dadaa90a10e2	Advil ® Tablets
66715-9700-3	2024-01-30	C162847	48780-1	1030e365-08c4-111a-e063-dadaa90a10e2	Advil ® Tablets
66715-9700-8	2024-01-30	C162847	48780-1	1030e365-08c4-111a-e063-dadaa90a10e2	Advil ® Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66715-6434-2	Advil	2 in 1 CARTON	TABLET, COATED	2	12
66715-6434-2	Advil	2 in 1 POUCH	TABLET, COATED	2	12
66715-6500-2	Advil	2 in 1 CARTON	TABLET, COATED	2	12
66715-6500-2	Advil	2 in 1 POUCH	TABLET, COATED	2	12
66715-9700-1	Advil	1 in 1 CARTON	TABLET, COATED	1	12
66715-9700-1	Advil	2 in 1 POUCH	TABLET, COATED	2	12
66715-9700-2	Advil	2 in 1 POUCH	TABLET, COATED	2	12
66715-9700-2	Advil	2 in 1 CARTON	TABLET, COATED	2	12
66715-9700-3	Advil	2 in 1 POUCH	TABLET, COATED	2	12
66715-9700-3	Advil	3 in 1 CARTON	TABLET, COATED	3	12
66715-9700-7	Advil	30 in 1 BOX, UNIT-DOSE	TABLET, COATED	30	12
66715-9700-7	Advil	2 in 1 POUCH	TABLET, COATED	2	12
66715-9700-8	Advil	6 in 1 CARTON	TABLET, COATED	6	12
66715-9700-8	Advil	2 in 1 POUCH	TABLET, COATED	2	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66715-6434	ADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	12	Current NDC, 2 package rows	20250130_772360bd-8631-4d24-b4db-5a7e6e1d9a13.zip
66715-6500	ADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	12	Current NDC, 2 package rows	20250130_772360bd-8631-4d24-b4db-5a7e6e1d9a13.zip
66715-9700	ADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	12	Current NDC, Legacy NDC, 10 package rows	20250130_772360bd-8631-4d24-b4db-5a7e6e1d9a13.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	2
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	2
diacetylated monoglycerides	INACTIVE INGREDIENT	5Z17386USF	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
shellac	INACTIVE INGREDIENT	46N107B71O	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	2
sucrose	INACTIVE INGREDIENT	C151H8M554	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	2
white wax	INACTIVE INGREDIENT	7G1J5DA97F	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Advil
Ibuprofen
DIACETYLATED MONOGLYCERIDES
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
METHYLPARABEN
MICROCRYSTALLINE CELLULOSE
SHELLAC
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66715-9700	66715-9700-1, 66715-9700-2, 66715-9700-3, 66715-9700-8, 66715-9700-7
66715-6500	66715-6500-2
66715-6434	66715-6434-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIACETYLATED MONOGLYCERIDES	5Z17386USF	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCROSE	C151H8M554	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WHITE WAX	7G1J5DA97F	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
DIACETYLATED MONOGLYCERIDES	5Z17386USF	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCROSE	C151H8M554	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WHITE WAX	7G1J5DA97F	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
DIACETYLATED MONOGLYCERIDES	5Z17386USF	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT

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 3 · 150 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
povidones	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	TABLET, COATED / ORAL	0.63 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
white wax	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	TABLET, COATED / ORAL	0.63 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	TABLET, COATED / ORAL	0.63 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
white wax	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
white wax	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	TABLET, COATED / ORAL	0.63 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	TABLET, COATED / ORAL	0.63 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	TABLET, COATED / ORAL	0.63 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 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
N018989-001	ADVIL	IBUPROFEN	200MG	TABLET / ORAL		RLD, RS	1984-05-18

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	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`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	Lil' Drug Store Products, Inc.	772360bd-8631-4d24-b4db-5a7e6e1d9a13	2025-01-27	Warnings	Exact identifier ndc (package): 66715-6434-2 ndc (package): 66715-9700-8 ndc (package): 66715-9700-2 ndc (package): 66715-6500-2 ndc (package): 66715-9700-3 ndc (package): 66715-9700-7 ndc (package): 66715-9700-1 ndc (product): 66715-6434 ndc (product): 66715-6500 ndc (product): 66715-9700 ndc11 (package): 66715970008 ndc11 (package): 66715970003 ndc11 (package): 66715643402 ndc11 (package): 66715650002 ndc11 (package): 66715970002 ndc11 (package): 66715970007 ndc11 (package): 66715970001 spl id: 2cb6ac3b-ffe3-21bc-e063-6394a90a4569 spl set id: 772360bd-8631-4d24-b4db-5a7e6e1d9a13

Reported adverse events (FAERS/openFDA)#

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