Ibuprofen

Product NDC
11822-0894
11-digit product format
118220894
Labeler code
11822
Product ID
11822-0894_2131107b-a8b1-4241-9bf2-e096b59cb19a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA206999
Marketing category
ANDA
Marketing start
2020-01-31
Marketing end
2026-12-31
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206999-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENRite Aid Corporation47657d95-4a54-49c2-8273-86b413b8f41e2025-07-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings 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: 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 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 the 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 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 take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain slurred speech trouble breathing leg swelling weaknessin one part or side of body 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, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely dir...

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0894-1Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1603
11822-0894-2Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED803
11822-0894-2Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
11822-0894-8Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3003
11822-0894-9Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED13
11822-0894-9Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0894IBUPROFEN CAPSULE, LIQUID FILLED [RITE AID CORPORATION]2Current NDC, Legacy NDC, 6 package rows20230221_47657d95-4a54-49c2-8273-86b413b8f41e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN47657d95-4a54-49c2-8273-86b413b8f41e3
310964ibuprofen 200 MG Oral CapsuleSCD47657d95-4a54-49c2-8273-86b413b8f41e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0894-111822089401160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11822-0894-1) 2020-01-312026-12-31NoNoCurrent
11822-0894-2118220894021 BOTTLE, PLASTIC in 1 CARTON (11822-0894-2) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-01-312026-12-31NoNoCurrent
11822-0894-811822089408300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11822-0894-8) 2020-01-312026-12-31NoNoCurrent
11822-0894-9118220894091 BOTTLE, PLASTIC in 1 BOX (11822-0894-9) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-01-312026-12-31NoNoCurrent