Otis Clapp Ultraprin

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
25
Source
full-release
Hydrated at
2026-06-01 01:13:09

Label at a glance#

ProductMedi-First Ibuprofen
Active ingredientIBUPROFEN
Label structure21 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ibuprofen 200 mg (NSAID)

*nonsteroidal antinflamatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches and pains associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

Temporarily reduces fever.

WARNINGS SECTION

Warnings

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

■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ 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 or 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.

OTC - DO NOT USE SECTION

Do not use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

■ you have problems or serious side effects from 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

■ 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

OTC - WHEN USING SECTION

When using this product

■ take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ 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 for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ redness or swelling is present in the painful area

■ any new or unexpected symptoms occur

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 at 20 weeks or later in pregnancy unless specifically 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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not use more than directed

■ the smallest effective dose should be used

■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

Adults and children:(12 years and older)

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 SAFETY INFORMATION

Other information

■ read all product information before using

■ store at 68-77°F (20-25°C)

■ avoid excessive heat 104°F (above 40°C )

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, povidone (K30)*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

Medi-First Ibuprofen Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medi-First®

Ibuprofen 200 mg

100 tablets (50 x 2)

Pain Reliever/Fever Reducer

Aches, Fever • Ibuprofen (NSAID) 200 mg

Pull to Open

Compare active ingredient to:

Advil®

Registered Trademark of Pfizer Consumer Healthcare

This Package is for Households without Young Children.

Tamper Evident Unit Dose Packets

100R Ibuprofen 80833 5-3-23 GR100R Ibuprofen 80833 5-3-23 GR

Medi-First Plus Ibuprofen Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medi-First® Plus

Ibuprofen

Ibuprofen 200 mg (NSAID)

100 Tablets (50 x 2’s)

Pull To Open

This Package isfor Households without Young Children.

Pain Reliever/Fever Reducer

Compare active ingredient to:

Advil®

Registered Trademark of Pfizer Consumer Healthcare

Tamper Evident Unit Dose Packets

100R Ibuprofen 90833 5-3-23 GR100R Ibuprofen 90833 5-3-23 GR

Medique Iprin Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique®

I-Prin

Ibuprofen 200 mg

Anti-Inflammatory (NSAID)

This Package is for Households without Young Children.

Pain Reliever/Fever Reducer • Ibuprofen 200 mg

24 Tablets (12 x 2)

Tamper Evident Unit Dose Packets.

100R 10069 5-3-23 GR100R 10069 5-3-23 GR

Dover Addaprin Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dover Addaprin™

Ibuprofen 200 mg Tablets (NSAID)

Pain Reliever-Fever Reducer

This Package is for Households Without Young Children.

Dover Pharmaceutical

Products of the highest quality and effectiveness

Tamper Evident

Sealed Packets

Unit Dose Packs

500 Tablets

(250 Packets of 2)

100R Addaprin 1625314 5-3-23 GR100R Addaprin 1625314 5-3-23 GR

Otis Clapp Ultraprin Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OC Otis Clapp

Quality & Integrity Since 1840

Ultraprin ™

Pain Reliever-Fever Reducer (NSAID)

Ibuprofen Tablets USP 200 mg

For Deep Seated Pain

See Warnings and Directions on Side Panel

Tear Out Along Perforation To Dispense

Professional Healthcare

500 Tablets (250 Packets of 2)

Otis Clapp Ultraprin Label 1-31-19Otis Clapp Ultraprin Label 1-31-19

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
900434Addaprin 200 MG Oral TabletPSN25
310965ibuprofen 200 MG Oral TabletPSN25
900438Ultraprin 200 MG Oral TabletPSN25
900434ibuprofen 200 MG Oral Tablet [Addaprin]SBD25
900438ibuprofen 200 MG Oral Tablet [Ultraprin]SBD25
310965ibuprofen 200 MG Oral TabletSCD25
900434Addaprin 200 MG Oral TabletSY25
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY25
900438Ultraprin 200 MG Oral TabletSY25

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-700-13Medique Iprin2 in 1 PACKETTABLET, COATED225
47682-700-13Medique Iprin250 in 1 BOXTABLET, COATED25025
47682-700-47Medique Iprin2 in 1 PACKETTABLET, COATED225
47682-700-47Medique Iprin100 in 1 BOXTABLET, COATED10025
47682-700-64Medique Iprin12 in 1 BOXTABLET, COATED1225
47682-700-64Medique Iprin2 in 1 PACKETTABLET, COATED225
47682-700-69Medique Iprin3 in 1 BOXTABLET, COATED325
47682-700-99Medique Iprin2 in 1 PACKETTABLET, COATED225
47682-702-13Otis Clapp Ultraprin250 in 1 BOXTABLET, COATED25025
47682-702-99Otis Clapp Ultraprin2 in 1 PACKETTABLET, COATED225
47682-709-33Medi-First Plus Ibuprofen50 in 1 BOXTABLET, COATED5025
47682-709-33Medi-First Plus Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-709-48Medi-First Plus Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-709-48Medi-First Plus Ibuprofen125 in 1 BOXTABLET, COATED12525
47682-714-13Dover Addaprin250 in 1 BOXTABLET, COATED25025
47682-714-99Dover Addaprin2 in 1 PACKETTABLET, COATED225
47682-718-13Medi-First Ibuprofen250 in 1 BOXTABLET, COATED25025
47682-718-30Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-30Medi-First Ibuprofen4 in 1 BOXTABLET, COATED425
47682-718-33Medi-First Ibuprofen50 in 1 BOXTABLET, COATED5025
47682-718-33Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-48Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-48Medi-First Ibuprofen125 in 1 BOXTABLET, COATED12525
47682-718-50Medi-First Ibuprofen25 in 1 BOXTABLET, COATED2525
47682-718-50Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-99Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM3
IbuprofenACTIVE MOIETYWK2XYI10QM3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6753
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X3
POVIDONE K30INACTIVE INGREDIENTU725QWY32X3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A23
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3
TRIACETININACTIVE INGREDIENTXHX3C3X6733

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

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 3 · 171 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, COATED / ORAL1301 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, COATED / ORAL1301 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, COATED / ORAL1301 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, COATED / ORAL1301 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
19 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079174-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2010-12-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1084e616aacf4f…
2026-08-18 06:07:402026-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10f41ea6bd6efb…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalgreensDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLWalgreen Co.5630f48b-404c-b847-e063-6394a90a8d8e2026-07-09WarningsExact identifier
ndc (package): 47682-718-99
ndc11 (package): 47682071899
Care ScienceDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLASO LLC562f2b2c-d234-e491-e063-6294a90a705f2026-07-08WarningsExact identifier
ndc (package): 47682-718-99
ndc11 (package): 47682071899
Medique IprinIBUPROFENUnifirst First Aid Corporation0607edb0-1b3a-2ccd-e054-00144ff8d46c2025-09-09WarningsExact identifier
ndc (package): 47682-718-33
ndc (package): 47682-718-13
ndc (package): 47682-700-13
ndc (package): 47682-702-13
ndc (package): 47682-718-99
ndc (package): 47682-700-47
ndc (package): 47682-718-50
ndc (package): 47682-700-64
ndc (package): 47682-714-13
ndc (package): 47682-700-69
ndc (package): 47682-709-48
ndc (package): 47682-718-30
ndc (package): 47682-700-99
ndc (package): 47682-718-48
ndc (package): 47682-709-33
ndc (package): 47682-714-99
ndc (package): 47682-702-99
ndc (product): 47682-709
ndc (product): 47682-718
ndc (product): 47682-700
ndc (product): 47682-702
ndc (product): 47682-714
ndc11 (package): 47682071899
ndc11 (package): 47682070213
ndc11 (package): 47682070948
ndc11 (package): 47682071848
ndc11 (package): 47682071413
ndc11 (package): 47682071833
ndc11 (package): 47682070013
ndc11 (package): 47682070099
ndc11 (package): 47682071850
ndc11 (package): 47682070299
ndc11 (package): 47682070069
ndc11 (package): 47682070064
ndc11 (package): 47682070047
ndc11 (package): 47682070933
ndc11 (package): 47682071499
ndc11 (package): 47682071813
ndc11 (package): 47682071830
spl id: 3e5d5179-6101-176d-e063-6394a90aed0c
spl set id: 0607edb0-1b3a-2ccd-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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