Health Mart Ibuprofen

Product NDC
62011-0015
11-digit product format
620110015
Labeler code
62011
Product ID
62011-0015_c9dd20f8-38d4-4baa-b403-dd2602697c8e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA072096
Marketing category
ANDA
Marketing start
2011-11-21
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct62011-0015DDiscontinued by firm2026-07-31
excluded packagepackage62011-001562011-0015-1DDiscontinued by firm2026-07-31
excluded packagepackage62011-001562011-0015-2DDiscontinued by firm2026-07-31
excluded packagepackage62011-001562011-0015-3DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen085dcc1a-e4b0-4d08-9476-72275382d1a12026-05-15WarningsExact identifier
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsExact identifier
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsExact identifier
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
ibuprofenIBUPROFENNorthwind Health Company, LLCda6c2802-5d15-dbcb-e053-2a95a90a25612026-01-01WarningsExact identifier
good sense ibuprofenIBUPROFENL. Perrigo Company70d0a429-27c1-43a5-b2ea-a9919e0910f82025-12-22WarningsExact identifier
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsExact identifier
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.c447fc6b-e9ef-447a-9609-5f893e18dfa72025-11-17WarningsExact identifier
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact 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 ibuprofen or any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • 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, kidney disease, asthma, or had a stroke • you are taking a diuretic 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 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 • 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 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 ...

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0015-1EA - Each62011-00154523db77-6cb9-4819-81be-7a689e08db5612012-07-24
62011-0015-2EA - Each62011-0015b40f6ffa-d666-4f56-b4e0-23cbce84491c12012-07-24
62011-0015-3EA - Each62011-001579ef969f-1dcf-44cc-9e1a-c67657d466ea12017-06-15

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0015-1620110015011 BOTTLE in 1 CARTON (62011-0015-1) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-11-210000-00-00NoNoCurrent
62011-0015-2620110015021 BOTTLE in 1 CARTON (62011-0015-2) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-11-210000-00-00NoNoCurrent
62011-0015-362011001503500 TABLET, FILM COATED in 1 BOTTLE (62011-0015-3) 2017-02-200000-00-00NoNoCurrent