Ibuprofen

Manufacturer: AAA Pharmaceutical, Inc.
Effective date: 2024-12-06
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:41:26

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) adults and children 12 years and over take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor

Storage and handling

store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) read all warnings and directions before use retain carton for complete product information

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 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
- backache
- the common cold
- minor pain of arthritis
- toothache
- menstrual cramps
- muscular aches
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
shock
facial swelling
skin reddening
asthma (wheezing)
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

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, or asthma
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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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
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 during the last 3 months of 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
do not take longer than 10 days, unless directed by a doctor (see Warnings)

adults and children 12 years and over	take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20°-25°C (68°-77°F)
avoid excessive heat above 40°C (104°F)
read all warnings and directions before use
retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, pregelatinized starch, sodium carboxymellose, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

SPL UNCLASSIFIED SECTION

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RESTORE u

NDC 57344-110-03

†COMPARE TO THE ACTIVE
INGREDIENT IN ADVIL ^®

Ibuprofen
Tablets, USP 200 mg

Pain Reliever, Fever Reducer

(NSAID)

100 COATED CAPLETS** (**capsule-shaped tablets)

Principal Display Panel - 100 Tablet Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	6
310965	ibuprofen 200 MG Oral Tablet	SCD	6
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	6

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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57344-110-01	Ibuprofen	1 in 1 CARTON	TABLET, COATED	1	6
57344-110-01	Ibuprofen	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	6
57344-110-02	Ibuprofen	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	6
57344-110-02	Ibuprofen	1 in 1 CARTON	TABLET, COATED	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57344-110	IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20241210_39e55ec1-213f-4996-adca-68a5ffbc409b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	1
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
dextrose monohydrate	INACTIVE INGREDIENT	LX22YL083G	1
Egg Phospholipids	INACTIVE INGREDIENT	1Z74184RGV	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	1
povidone K30	INACTIVE INGREDIENT	U725QWY32X	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Sodium Starch Glycolate Type A Corn	INACTIVE INGREDIENT	AG9B65PV6B	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	1

Products#

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

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

Ibuprofen
SILICON DIOXIDE
STARCH, CORN
DEXTROSE MONOHYDRATE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
EGG PHOSPHOLIPIDS
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POVIDONE, UNSPECIFIED
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57344-110	57344-110-01, 57344-110-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
DEXTROSE MONOHYDRATE	LX22YL083G	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
IBUPROFEN	WK2XYI10QM	ACTIB

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 1 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, COATED / ORAL	3.2 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TROCHE / ORAL		4440 mg	Exact identifier — unii+route 15 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	GRANULE, FOR SUSPENSION / ORAL		15009 mg	Exact identifier — unii+route 15 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET, EXTENDED RELEASE / ORAL		92 mg	Exact identifier — unii+route 15 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	TABLET, COATED / ORAL		160 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	CAPSULE / ORAL		345 mg	Exact identifier — unii+route 15 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	TABLET, COATED / ORAL		160 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TROCHE / ORAL		4440 mg	Exact identifier — unii+route 15 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, COATED / ORAL	3.2 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, COATED / ORAL	3.2 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	CAPSULE / ORAL		345 mg	Exact identifier — unii+route 15 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	CAPSULE / ORAL		345 mg	Exact identifier — unii+route 15 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TROCHE / ORAL		4440 mg	Exact identifier — unii+route 15 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET / ORAL		11 mg	Exact identifier — unii+route 15 equally ranked IID candidates
Egg Phospholipids	EGG PHOSPHOLIPIDS	1Z74184RGV	TABLET / ORAL		48 mg	Exact identifier — unii+route 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	GRANULE, FOR SUSPENSION / ORAL		15009 mg	Exact identifier — unii+route 15 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Egg Phospholipids	EGG PHOSPHOLIPIDS	1Z74184RGV	TABLET / ORAL		48 mg	Exact identifier — unii+route 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET / ORAL		11 mg	Exact identifier — unii+route 15 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	GRANULE, FOR SUSPENSION / ORAL		15009 mg	Exact identifier — unii+route 15 equally ranked IID candidates
Egg Phospholipids	EGG PHOSPHOLIPIDS	1Z74184RGV	TABLET / ORAL		48 mg	Exact identifier — unii+route 3 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET / ORAL		11 mg	Exact identifier — unii+route 15 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET, EXTENDED RELEASE / ORAL		92 mg	Exact identifier — unii+route 15 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
dextrose monohydrate	DEXTROSE MONOHYDRATE	LX22YL083G	TABLET, EXTENDED RELEASE / ORAL		92 mg	Exact identifier — unii+route 15 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	TABLET, COATED / ORAL		160 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 3 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
A079129-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-03-28

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`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
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	39e55ec1-213f-4996-adca-68a5ffbc409b	2024-12-06	Warnings	Exact identifier ndc (package): 57344-110-01 ndc (package): 57344-110-02 ndc (product): 57344-110 ndc11 (package): 57344011002 ndc11 (package): 57344011001 spl id: 289b7de2-bf15-48ea-e063-6394a90a2f9d spl set id: 39e55ec1-213f-4996-adca-68a5ffbc409b

Reported adverse events (FAERS/openFDA)#

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