Ibuprofen

Product NDC
69842-851
11-digit product format
698420851
Labeler code
69842
Product ID
69842-851_f6f48d8e-bfda-414f-b667-bd57156b55db
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA206999
Marketing category
ANDA
Marketing start
2018-09-30
Marketing end
2025-05-30
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
Listing certified through
0000-00-00
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 productproduct69842-851DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-02DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-03DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-05DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-16DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-20DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-40DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-60DDiscontinued by firm2026-07-31
excluded packagepackage69842-85169842-851-80DDiscontinued 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-851-022020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-032020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-052020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-162020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-202020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-402020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-602020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-802020-10-26C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-022020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-032020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-052020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-162020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-202020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-402020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-602020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-802020-09-27C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-022020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-032020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-052020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-162020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-202020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-402020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-602020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-802020-09-25C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-022020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-032020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-052020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-162020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-202020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-402020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-602020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts
69842-851-802020-07-22C16284748780-1ab0e2407-2af7-f274-e053-dbdaa90a6471Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-851IBUPROFEN CAPSULE, LIQUID FILLED [CVS PHARMACY]4Legacy NDC20221123_899c3826-9965-4950-a336-8d186ccbf61c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-851-0269842085102200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-851-02) 2018-09-300000-00-00NoNoCurrent
69842-851-0369842085103300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-851-03) 2018-09-300000-00-00NoNoCurrent
69842-851-0569842085105500 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-851-05) 2018-09-300000-00-00NoNoCurrent
69842-851-16698420851162 BOTTLE, PLASTIC in 1 BOX (69842-851-16) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-09-300000-00-00NoNoCurrent
69842-851-20698420851201 BOTTLE, PLASTIC in 1 BOX (69842-851-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-09-300000-00-00NoNoCurrent
69842-851-40698420851401 BOTTLE, PLASTIC in 1 BOX (69842-851-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-09-300000-00-00NoNoCurrent
69842-851-6069842085160160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-851-60) 2018-09-300000-00-00NoNoCurrent
69842-851-806984208518080 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-851-80) 2018-09-300000-00-00NoNoCurrent