Cedaprin

Manufacturer: Honeywell Safety Products USA, Inc
Effective date: 2024-01-19
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: legacy-cache
Hydrated at: 2026-08-01 21:13:50

Label at a glance#

ProductCedaprin

Active ingredientIBUPROFEN

Label structure11 sections

Indications and uses

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

Dosage and administration

do not take more than directed the smallest effective dose should be used adult and children 12 years of age 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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-430-5490

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)

*(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
muscular aches
minor pain of arthritis
toothache
backache
the common cold
menstrual cramps

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 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:

NSAID's, 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 ibuprofen or any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have problems or serious side effectsfrom taking pain relievers or fever reducers
stomach bleeding warning applies to you
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 a pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit of aspirin
under a doctors care for any serious condition
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 oe 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 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
the smallest effective dose should be used
adult and children 12 years of age 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

OTHER SAFETY INFORMATION

store between 15 ^o-30 ^oC (59 ^o-86 ^oF)
avoid excessive heat and humidity
TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, lactose monohydrate, opadry II 31K, povidone K-30, ferric oxide red, silicon dioxide, starch, stearic acid, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-430-5490

Cedaprin Old

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1 Cedaprin 500ct carton Enter section text here

Cedaprin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cedaprin

Cedeprin 7502

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cedeprin gran

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

Cedaprin
Ibuprofen
TRIACETIN
STARCH, CORN
POVIDONE K30
FERRIC OXIDE RED
TITANIUM DIOXIDE
SILICON DIOXIDE
STEARIC ACID
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSES
CROSCARMELLOSE SODIUM
POLYETHYLENE GLYCOL
CELLULOSE, MICROCRYSTALLINE
FD&C RED NO. 40
FD&C BLUE NO. 2
CARNAUBA WAX
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MALTODEXTRIN
POLYDEXTROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0498-7502	0498-7502-01, 0498-7502-10, 0498-7502-25, 0498-7502-50
0498-7500	0498-7500-01, 0498-7500-10, 0498-7500-25, 0498-7500-50
0498-7501	0498-7501-01, 0498-7501-10, 0498-7501-25, 0498-7501-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TRIACETIN	XHX3C3X673	IACT
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE K30	U725QWY32X	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 6 · 311 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET / ORAL		320 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	GRANULE / ORAL		150 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, COATED PELLETS / ORAL		198 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION, EXTENDED RELEASE / ORAL	0.12 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, ORALLY DISINTEGRATING / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SUSPENSION / ORAL		6040 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, EXTENDED RELEASE / ORAL	2.78 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 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
1a516f21-b83b-494f-e063-6394a90a4d3c			82392922-edec-4a98-a0d9-9a5fe33fd39a	2024-06-07	Warnings	Exact identifier spl set id: 82392922-edec-4a98-a0d9-9a5fe33fd39a

Reported adverse events (FAERS/openFDA)#

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