Motrin IB

Manufacturer: Lil' Drug Store Products, Inc.
Effective date: 2023-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: legacy-cache
Hydrated at: 2026-08-01 21:19:07

Label at a glance#

ProductMotrin IB

Active ingredientIBUPROFEN

Label structure14 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 adults and children 12 years and older 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

read all warnings and directions before use store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) do not use if pouch is torn or damaged

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-895-3665

PhoneLabel contact215-273-8755

Websitewww.motrin.com

www.motrin.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID) ¹

1 nonsteroidal anti-inflammatory drug

Purposes

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

SPL UNCLASSIFIED SECTION

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chances are 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 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 effects from taking pain relievers or fever reducers
the 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, or kidney disease
you have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor's 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
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

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. (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 older	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

read all warnings and directions before use
store at 20-25°C (68-77°F)
avoid high humidity and excessive heat above 40°C (104°F)
do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division

Fort Washington, PA 19034 USA

Repackaged and distributed by Convenience Valet ^®, Glendale Heights, IL 60139

PRINCIPAL DISPLAY PANEL - 200 mg Caplet Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

minimum annual

$250,000

Donation

See details on back.

Children's

Miracle Network

Hospitals ^®

New Information: Read Entire Label

Motrin ^®IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever / Fever Reducer (NSAID)

FPO

2 Pouches

of 2 Coated

Caplets* Each

*Capsule-Shaped Tablets

Principal Display Panel - 200 mg Caplet Pouch Package

PRINCIPAL DISPLAY PANEL-200mg Caplet Pouch 6ct Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Information: Read Entire Label

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

3 POUCHES OF 2 COATED CAPLETS* EACH

*Capsule-Shaped Tablets

Motrin 6ct

PRINCIPAL DISPLAY PANEL-200mg Caplet Pouch 30ct Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

Convenient Take-Along Packs

Coated Caplets** Do not use if pouch is torn or damaged.

**Capsule-Shaped Tablets

30 POUCHES OF 2 COATED CAPLETS* EACH

Motrin 30ct

Mortin CVP 4 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See Revised Warnings

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplet image]

4 Coated Caplets**

2 POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

CVP

HEALTH

Motrin CVP 4ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
29485-1465-4	2020-11-16	C162847	48780-1	9d75b9d0-ecbf-f424-e053-dadaa90a57ce	Motrin ® IB
29485-1465-4	2020-01-31	C162847	48780-1	9d75b9d0-ecbf-f424-e053-dadaa90a57ce	Motrin ® IB

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-1465	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	10	Legacy NDC	20231207_5715910e-33be-49bd-8a1f-eeb46320e28d.zip
29485-6512	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	10	Unmatched	20231207_5715910e-33be-49bd-8a1f-eeb46320e28d.zip
29485-7006	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	10	Legacy NDC	20231207_5715910e-33be-49bd-8a1f-eeb46320e28d.zip
29485-7938	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	10	Legacy NDC	20231207_5715910e-33be-49bd-8a1f-eeb46320e28d.zip

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
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Shellac	INACTIVE INGREDIENT	46N107B71O	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	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 · 15 matching rows.

Motrin IB
Ibuprofen
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
STEARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
29485-7006	29485-7006-3
29485-7938	29485-7938-6
29485-1465	29485-1465-4
29485-6512	29485-6512-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 56 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
STEARIC ACID	4ELV7Z65AP	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 7 · 366 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	LOTION / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Shellac	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	LIQUID / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Shellac	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019012-001	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1984-05-18
N019012-002	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1987-07-29
N019012-003	MOTRIN IB	IBUPROFEN	200MG	TABLET / ORAL	RLD	1990-12-17
N019012-004	MOTRIN MIGRAINE PAIN	IBUPROFEN	200MG	TABLET / ORAL		2000-02-25

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`5bbf6a4d5a75…`

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
0bca1920-4b72-76de-e063-6394a90a7ffb			5715910e-33be-49bd-8a1f-eeb46320e28d	2023-12-05	Warnings	Exact identifier spl id: 0bca1920-4b72-76de-e063-6394a90a7ffb spl set id: 5715910e-33be-49bd-8a1f-eeb46320e28d

Reported adverse events (FAERS/openFDA)#

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