FDA.reportPublic FDA data

good sense ibuprofen

Product NDC
0113-0604
11-digit product format
001130604
Labeler code
0113
Product ID
0113-0604_822f5bcb-7dcf-454a-8d76-8ce8aaa40d4c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA072096
Marketing category
ANDA
Marketing start
1989-09-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0604-02good sense ibuprofen550 in 1 BOTTLETABLET, FILM COATED55011
0113-0604-52good sense ibuprofen10 in 1 VIALTABLET, FILM COATED1011
0113-0604-62good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED111
0113-0604-62good sense ibuprofen24 in 1 BOTTLETABLET, FILM COATED2411
0113-0604-71good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED111
0113-0604-71good sense ibuprofen50 in 1 BOTTLETABLET, FILM COATED5011
0113-0604-76good sense ibuprofen120 in 1 BOTTLETABLET, FILM COATED12011
0113-0604-76good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED111
0113-0604-78good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED111
0113-0604-78good sense ibuprofen100 in 1 BOTTLETABLET, FILM COATED10011
0113-0604-82good sense ibuprofen100 in 1 BOTTLETABLET, FILM COATED10011
0113-0604-82good sense ibuprofen2 in 1 CARTONTABLET, FILM COATED211
0113-0604-85good sense ibuprofen250 in 1 BOTTLETABLET, FILM COATED25011
0113-0604-90good sense ibuprofen500 in 1 BOTTLETABLET, FILM COATED50011
0113-0604-93good sense ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0604-02EA - Each0113-060466f5079e-a6c0-46da-aa15-9c6385c3a23912021-08-05
0113-0604-52EA - Each0113-060421b758f3-80e9-452b-a256-032323c9f89a12017-06-15
0113-0604-62EA - Each0113-060458beaaf5-e484-41ae-b6bb-e53673ead98412012-07-24
0113-0604-71EA - Each0113-0604fb9683a6-d3db-4007-8cc8-96e0cffed12812012-07-24
0113-0604-76EA - Each0113-06040eb72303-0c2d-4823-8e2d-d93cf85fec8512018-02-20
0113-0604-78EA - Each0113-060486b9b718-0b7b-4fce-8133-b95e6032516312012-07-24
0113-0604-82EA - Each0113-0604739ea372-2641-473a-981b-8cb71615c99b12021-07-15
0113-0604-90EA - Each0113-0604f72ffec1-5b1a-494f-8763-7e63b811bce612012-07-24
0113-0604-93EA - Each0113-06040a50ceae-a73f-4cf6-8db1-95dda007fe7c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L PERRIGO COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0604GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L. PERRIGO COMPANY]10Current NDC, Legacy NDC, 15 package rows20250418_70d0a429-27c1-43a5-b2ea-a9919e0910f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNd6460cc3-c207-44e0-bf78-ad6fef055ed5102
310965ibuprofen 200 MG Oral TabletSCDd6460cc3-c207-44e0-bf78-ad6fef055ed5102
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYd6460cc3-c207-44e0-bf78-ad6fef055ed5102
310965ibuprofen 200 MG Oral TabletPSN70d0a429-27c1-43a5-b2ea-a9919e0910f811
310965ibuprofen 200 MG Oral TabletSCD70d0a429-27c1-43a5-b2ea-a9919e0910f811
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY70d0a429-27c1-43a5-b2ea-a9919e0910f811
310965ibuprofen 200 MG Oral TabletPSN9ac095d2-ba19-4da1-acc9-85f7b4ae304d4
310965ibuprofen 200 MG Oral TabletSCD9ac095d2-ba19-4da1-acc9-85f7b4ae304d4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY9ac095d2-ba19-4da1-acc9-85f7b4ae304d4
310965ibuprofen 200 MG Oral TabletPSNf1a03b1f-2d87-43cc-b256-bd296ccd09f23
310965ibuprofen 200 MG Oral TabletSCDf1a03b1f-2d87-43cc-b256-bd296ccd09f23
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf1a03b1f-2d87-43cc-b256-bd296ccd09f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0604-0200113060402550 TABLET, FILM COATED in 1 BOTTLE (0113-0604-02) 2013-06-200000-00-00NoNoCurrent
0113-0604-520011306045210 TABLET, FILM COATED in 1 VIAL (0113-0604-52) 1991-04-150000-00-00NoNoCurrent
0113-0604-62001130604621 BOTTLE in 1 CARTON (0113-0604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1992-05-040000-00-00NoNoCurrent
0113-0604-71001130604711 BOTTLE in 1 CARTON (0113-0604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1989-09-150000-00-00NoNoCurrent
0113-0604-76001130604761 BOTTLE in 1 CARTON (0113-0604-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-06-150000-00-00NoNoCurrent
0113-0604-78001130604781 BOTTLE in 1 CARTON (0113-0604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1989-09-150000-00-00NoNoCurrent
0113-0604-82001130604822 BOTTLE in 1 CARTON (0113-0604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2011-03-020000-00-00NoNoCurrent
0113-0604-8500113060485250 TABLET, FILM COATED in 1 BOTTLE (0113-0604-85) 2020-12-120000-00-00NoNoCurrent
0113-0604-9000113060490500 TABLET, FILM COATED in 1 BOTTLE (0113-0604-90) 1993-01-180000-00-00NoNoCurrent
0113-0604-93001130604931000 TABLET, FILM COATED in 1 BOTTLE (0113-0604-93) 2007-05-310000-00-00NoNoCurrent