Ibuprofen

Product NDC
37808-750
11-digit product format
378080750
Labeler code
37808
Product ID
37808-750_be03d741-195e-44b2-94ba-d860f31f5ede
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
H E B
Application
ANDA206999
Marketing category
ANDA
Marketing start
2018-08-31
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37808-750DDiscontinued by firm2026-07-31
excluded packagepackage37808-75037808-750-20DDiscontinued by firm2026-07-31
excluded packagepackage37808-75037808-750-30DDiscontinued by firm2026-07-31
excluded packagepackage37808-75037808-750-40DDiscontinued by firm2026-07-31
excluded packagepackage37808-75037808-750-80DDiscontinued by firm2026-07-31

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
Dolex FlexIBUPROFENPharmadel LLC822d9def-504c-9beb-e053-2991aa0a280e2023-09-13WarningsExact identifier
IbuprofenIBUPROFENCostco Wholesaleeb62ed66-cafd-4d09-acc9-b9abf748ba852022-10-11WarningsExact 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...

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-750IBUPROFEN CAPSULE, LIQUID FILLED [H E B]4Legacy NDC20230213_a835d470-da77-4f56-a1ab-d4f02353483b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-750-20378080750201 BOTTLE, PLASTIC in 1 BOX (37808-750-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-08-310000-00-00NoNoCurrent
37808-750-3037808075030300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (37808-750-30) 2018-08-310000-00-00NoNoCurrent
37808-750-40378080750401 BOTTLE, PLASTIC in 1 BOX (37808-750-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-08-310000-00-00NoNoCurrent
37808-750-803780807508080 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (37808-750-80) 2018-08-310000-00-00NoNoCurrent