Ibuprofen

Manufacturer: MARKSANS PHARMA LIMITED
Effective date: 2023-04-03
Label type: Human OTC Drug Label
Version: 11
Source: full-release
Hydrated at: 2026-05-31 23:54:38

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure16 sections

Indications and uses

• temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o the common cold o muscular aches o 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 capsule every 4 to 6 hours while symptoms persist if pain or fever does 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#

PhoneLabel contact1-877-376-4271

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert: 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 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: 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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 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 capsule every 4 to 6 hours while symptoms persist
if pain or fever does 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. Keep carton.
• store at 20-25ºC (68-77ºF)
• avoid excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, FD&C Green No. 3, gelatin, iron oxide black, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-877-376-4271

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen capsules 200 mg (Liquid Filled Capsules)

NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)
10's count bottle label

NDC 25000-133-43

Ibuprofen capsules 200 mg (Liquid filled capsules)
10's count carton label

NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)
20's count bottle label

NDC 25000-133-01

Ibuprofen capsules 200 mg (Liquid filled capsules)
20's count carton label

NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)
32's count bottle label

NDC 25000-133-04

Ibuprofen capsules 200 mg (Liquid filled capsules)
32's count carton label

NDC 25000-133-69

Ibuprofen capsules 200 mg (Liquid filled capsules)
300's count bottle label

NDC 25000-133-13

Ibuprofen capsules 200 mg (Liquid filled capsules)
600's count bottle label

Ibuprofen capsules 200 mg (Mini liquid filled capsules)

NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
10's count bottle label

NDC 25000-062-43

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
10's count carton label

NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
20's count bottle label

NDC 25000-062-01

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
20's count carton label

NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
32's count bottle label

NDC 25000-062-04

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
32's count carton label

NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
80's count bottle label

NDC 25000-062-67

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
80's count carton label

NDC 25000-062-69

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
300's count PET bottle label

NDC 25000-062-13

Ibuprofen capsules 200 mg (Mini liquid filled capsules)
600's count bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310964	ibuprofen 200 MG Oral Capsule	PSN	11
310964	ibuprofen 200 MG Oral Capsule	SCD	11

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25000-062-01	Ibuprofen	20 in 1 BOTTLE	CAPSULE, LIQUID FILLED	20	11
25000-062-01	Ibuprofen	01 in 1 CARTON	CAPSULE, LIQUID FILLED	01	11
25000-062-04	Ibuprofen	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11
25000-062-04	Ibuprofen	32 in 1 BOTTLE	CAPSULE, LIQUID FILLED	32	11
25000-062-13	Ibuprofen	600 in 1 BOTTLE	CAPSULE, LIQUID FILLED	600	11
25000-062-43	Ibuprofen	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11
25000-062-43	Ibuprofen	10 in 1 BOTTLE	CAPSULE, LIQUID FILLED	10	11
25000-062-67	Ibuprofen	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11
25000-062-67	Ibuprofen	80 in 1 BOTTLE	CAPSULE, LIQUID FILLED	80	11
25000-062-69	Ibuprofen	300 in 1 BOTTLE	CAPSULE, LIQUID FILLED	300	11
25000-062-87	Ibuprofen	2500 in 1 BAG	CAPSULE, LIQUID FILLED	2500	11
25000-062-87	Ibuprofen	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	11
25000-133-01	Ibuprofen	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11
25000-133-01	Ibuprofen	20 in 1 BOTTLE	CAPSULE, LIQUID FILLED	20	11
25000-133-04	Ibuprofen	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11
25000-133-04	Ibuprofen	32 in 1 BOTTLE	CAPSULE, LIQUID FILLED	32	11
25000-133-13	Ibuprofen	600 in 1 BOTTLE	CAPSULE, LIQUID FILLED	600	11
25000-133-13	Ibuprofen	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	11
25000-133-18	Ibuprofen	4 in 1 BOX	CAPSULE, LIQUID FILLED	4	11
25000-133-18	Ibuprofen	2500 in 1 BAG	CAPSULE, LIQUID FILLED	2500	11
25000-133-23	Ibuprofen	5 in 1 DRUM	CAPSULE, LIQUID FILLED	5	11
25000-133-23	Ibuprofen	2000 in 1 BAG	CAPSULE, LIQUID FILLED	2000	11
25000-133-43	Ibuprofen	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11
25000-133-43	Ibuprofen	10 in 1 BOTTLE	CAPSULE, LIQUID FILLED	10	11
25000-133-69	Ibuprofen	300 in 1 BOTTLE	CAPSULE, LIQUID FILLED	300	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25000-062	IBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]	11	Current NDC, Legacy NDC, 12 package rows	20230406_403ec259-3be1-4e0b-ab7b-fee213b7eabe.zip
25000-133	IBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]	11	Current NDC, Legacy NDC, 13 package rows	20230406_403ec259-3be1-4e0b-ab7b-fee213b7eabe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	3
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

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, UNSPECIFIED
SORBITOL
WATER
SHELLAC
SORBITAN MONOOLEATE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
FERROUS OXIDE
MEDIUM-CHAIN TRIGLYCERIDES

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
25000-062	25000-062-43, 25000-062-01, 25000-062-04, 25000-062-67, 25000-062-13, 25000-062-87, 25000-062-69
25000-133	25000-133-23, 25000-133-18, 25000-133-04, 25000-133-13, 25000-133-43, 25000-133-01, 25000-133-69

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
AMMONIA	5138Q19F1X	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
SHELLAC	46N107B71O	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
FERROUS OXIDE	G7036X8B5H	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
AMMONIA	5138Q19F1X	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
SHELLAC	46N107B71O	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
FERROUS OXIDE	G7036X8B5H	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	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 18 · 1,056 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SHELLAC	SHELLAC	46N107B71O	TABLET, FILM COATED / ORAL	4.4 mg		Exact identifier — unii+route 192 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 112 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, FILM COATED / ORAL	4.4 mg		Exact identifier — unii+route 192 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 192 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route 192 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 288 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, COATED / ORAL	0.13 mg		Exact identifier — unii+route 112 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED / ORAL		12 mg	Exact identifier — unii+route 112 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, LIQUID FILLED / ORAL	0.03 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 192 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii+route 288 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 320 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii+route 320 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii+route 288 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii+route 112 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET / ORAL		19 mg	Exact identifier — unii+route 112 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii+route 288 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 288 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	SUSPENSION / ORAL	3 mg/1ml		Exact identifier — unii+route 192 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route 192 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii+route 320 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route 320 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 320 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 192 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, LIQUID FILLED / ORAL	0.03 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route 288 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii+route 320 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET / ORAL		19 mg	Exact identifier — unii+route 112 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii+route 192 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 112 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	CAPSULE / ORAL		288 mg	Exact identifier — unii+route 112 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii+route 288 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 288 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii+route 288 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii+route 192 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route 192 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 288 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 288 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, LIQUID FILLED / ORAL	0.03 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, LIQUID FILLED / ORAL	0.03 mg		Exact identifier — unii+route+dosage form 16 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route 192 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii+route 320 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 288 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 288 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED / ORAL		12 mg	Exact identifier — unii+route 112 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii+route 112 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii+route 288 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
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	403ec259-3be1-4e0b-ab7b-fee213b7eabe	2023-04-03	Warnings	Exact identifier ndc (package): 25000-133-43 ndc (package): 25000-133-01 ndc (package): 25000-062-04 ndc (package): 25000-133-18 ndc (package): 25000-062-43 ndc (package): 25000-133-04 ndc (package): 25000-062-13 ndc (package): 25000-062-01 ndc (package): 25000-133-69 ndc (package): 25000-062-69 ndc (package): 25000-062-67 ndc (package): 25000-133-23 ndc (package): 25000-133-13 ndc (package): 25000-062-87 ndc (product): 25000-062 ndc (product): 25000-133 ndc11 (package): 25000013323 ndc11 (package): 25000013343 ndc11 (package): 25000006204 ndc11 (package): 25000006267 ndc11 (package): 25000013313 ndc11 (package): 25000006213 ndc11 (package): 25000013301 ndc11 (package): 25000013369 ndc11 (package): 25000013318 ndc11 (package): 25000006201 ndc11 (package): 25000013304 ndc11 (package): 25000006287 ndc11 (package): 25000006243 ndc11 (package): 25000006269 spl id: 009afd24-3f12-4208-876d-f22ce92a40ce spl set id: 403ec259-3be1-4e0b-ab7b-fee213b7eabe

Reported adverse events (FAERS/openFDA)#

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