IBUPROFEN

Manufacturer: Walgreen Company | Aphena Pharma Solutions - Kentucky, LLC. | Marksans Pharma Limited
Effective date: 2012-05-22
Label type: Human OTC Drug Label
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:18

Label at a glance#

ProductIBUPROFEN

Active ingredientIBUPROFEN

Label structure16 sections

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 capsule every 4 to 6 hours while symptoms persist if pain or fever dose not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-586-7979

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Solubilized Ibuprofen equal to

200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alerts: 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: 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

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 doctor if

OTC - STOP USE SECTION

you experience any of following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that dose 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 painful area
any new symptoms appear

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 a problems in the unborn child or complications during delivery.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison ControlCenter right away.(1-800-222-1222)

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 capsule every 4 to 6 hours while symptoms persist
if pain or fever dose not respond to 1 capsule, 2 capsules may be used
do not exceed 6 capsules in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

each capsule contains: potassium 20 mg
read all warnings and directions before use.
store at 20-25 ^oC (68-77 ^oF)
avoid excessive heat above 40 ^oC (104 ^oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20ct_Carton

20ct_Label

OTC - QUESTIONS SECTION

Questions or Comments? 1-877-586-7979

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310964	ibuprofen 200 MG Oral Capsule	PSN	1
310964	ibuprofen 200 MG Oral Capsule	SCD	1

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
0363-0003-16	2019-11-13	C162847	48780-1	97449f38-b5b2-f6ea-e053-dbdaa90aa703	d4569486-e581-4671-b32c-1903abfa726e
0363-0003-20	2019-11-13	C162847	48780-1	97449f38-b5b2-f6ea-e053-dbdaa90aa703	d4569486-e581-4671-b32c-1903abfa726e
0363-0003-40	2019-11-13	C162847	48780-1	97449f38-b5b2-f6ea-e053-dbdaa90aa703	d4569486-e581-4671-b32c-1903abfa726e
0363-0003-80	2019-11-13	C162847	48780-1	97449f38-b5b2-f6ea-e053-dbdaa90aa703	d4569486-e581-4671-b32c-1903abfa726e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0003-16	IBUPROFEN	160 in 1 BOTTLE	CAPSULE, LIQUID FILLED	160	1
0363-0003-16	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	1
0363-0003-20	IBUPROFEN	20 in 1 BOTTLE	CAPSULE, LIQUID FILLED	20	1
0363-0003-20	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	1
0363-0003-40	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	1
0363-0003-40	IBUPROFEN	40 in 1 BOTTLE	CAPSULE, LIQUID FILLED	40	1
0363-0003-80	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	1
0363-0003-80	IBUPROFEN	80 in 1 BOTTLE	CAPSULE, LIQUID FILLED	80	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0003	IBUPROFEN CAPSULE, LIQUID FILLED [WALGREEN COMPANY]	1	Legacy NDC, 8 package rows	20120618_d4569486-e581-4671-b32c-1903abfa726e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

IBUPROFEN
AMMONIA
FD&C GREEN NO. 3
GELATIN
SORBITOL
WATER
SHELLAC
SORBITAN MONOOLEATE
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
MEDIUM-CHAIN TRIGLYCERIDES
POTASSIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-0003	0363-0003-20, 0363-0003-40, 0363-0003-80, 0363-0003-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
AMMONIA	5138Q19F1X	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
GELATIN	2G86QN327L	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
SHELLAC	46N107B71O	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT

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 5 · 268 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	DROPS / NASAL	50 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CREAM / TOPICAL		3300 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, FILM COATED / ORAL		57 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / INTRAVENOUS	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	CAPSULE / ORAL		288 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY / TOPICAL		540 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii candidate 13 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET / ORAL		19 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE, LIQUID FILLED / ORAL		154 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	LOTION / TOPICAL	ADJ PH		Exact identifier — unii candidate 14 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / SUBCUTANEOUS	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED / ORAL		288 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, COATED / ORAL	0.13 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	INJECTION / INTRAVENOUS	0.22 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 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
A079205-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-06-26

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	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`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
5ced2456-e28d-4dc7-8255-a27b22b486b7			d4569486-e581-4671-b32c-1903abfa726e	2012-05-22	Warnings	Exact identifier spl id: 5ced2456-e28d-4dc7-8255-a27b22b486b7 spl set id: d4569486-e581-4671-b32c-1903abfa726e

Reported adverse events (FAERS/openFDA)#

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