Ibuprofen

Product NDC
63981-393
11-digit product format
639810393
Labeler code
63981
Product ID
63981-393_a505176d-d118-4a10-885d-1d6e2b884252
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
COSTCO WHOLESALE CORPORATION
Application
ANDA075139
Marketing category
ANDA
Marketing start
1999-03-01
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63981-39363981-393-03DDiscontinued by firm2026-07-31
excluded packagepackage63981-39363981-393-58DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075139-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1999-03-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENBetter Living Brands, LLC45520969-7a2d-4469-ba25-7db160d50ccf2026-07-06WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.027ded51-aa01-6619-3938-c8162a421cf32026-06-18WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENCardinal Health 110, LLC. DBA Leadera41a0bc2-ef7a-44cd-a42e-aefab41323cc2026-06-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE01f8fe3a-8810-4b38-8860-d95e05d377092026-06-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENCardinal Health 107, LLC260f5862-d65d-4c34-bf53-26ca30806a672026-05-19WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENMeijer Distribution, Inc.3e3a5366-535d-45fb-81af-c7d98ac20b112026-05-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Ibuprofen Dye FreeIBUPROFENCVS Pharmacy00653b7c-7099-487e-9a01-e89781c213232026-04-29WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENMeijer Distribution Inc36f7227d-f3cb-44b7-a4c1-27611cd150522026-04-24WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENRite Aid Corporation72e11f2d-a348-4c12-9cd8-1e6f0f6f73992026-04-09WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Ibuprofen Dye-FreeIBUPROFENWal-Mart Stores Inc23cb5001-6aeb-434a-b2e8-aaf8bbab9dc62026-04-01WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Ibuprofen Dye FreeIBUPROFENWALMART INC.2b04d255-a1df-4698-9b5a-ad7a12205e1b2026-03-25WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
pain relief ibuprofenIBUPROFENRite Aid Corporation2bd1438e-27b1-81ff-f8e1-0f5b50b045812026-02-02WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENH E B88c7486b-f9a7-4856-a25a-7c06e1382f1a2026-02-02WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.82e907e6-86a9-5c7f-93bd-a6319d74100f2026-01-13WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.8ebe3e16-b7ae-d333-6671-5bc935e259002026-01-13WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENL.N.K. International, Inc.c93da67f-f42e-4baa-976b-73c71ba6dd712026-01-12WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENMajor Pharmaceuticals6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f62025-12-17WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
Dye Free IbuprofenIBUPROFENWalgreen Companyd3d093f9-207a-40d4-a7be-c6b5a544a0a72025-12-12WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENFamily Dollar Services Inc89ed9311-2185-4660-b219-9ea67b1a71ec2025-11-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139
IbuprofenIBUPROFENTopco Associates, LLCbcf7d4c1-1f99-48df-8f74-9abeefa8d41d2025-11-15WarningsExact identifier
application applno (ANDA): 075139
application number: ANDA075139

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310965Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b8ad98e-de76-4f49-3b89-01e9dd5cde16Available on FDA.report

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
63981-393-03Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1020
63981-393-03Ibuprofen1 in 1 PACKAGETABLET, FILM COATED120
63981-393-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020
63981-393-58Ibuprofen750 in 1 BOTTLE, PLASTICTABLET, FILM COATED75020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-393-14EA - Each63981-3935861ddbb-fb76-4a19-b699-d69d33628f0f12024-04-05
63981-393-58EA - Each63981-39365c0d30a-a4f3-457b-9d98-eaa08e95d81912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-393IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION]19Current NDC, Legacy NDC, 4 package rows20240825_4b8ad98e-de76-4f49-3b89-01e9dd5cde16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN4b8ad98e-de76-4f49-3b89-01e9dd5cde1620
310965ibuprofen 200 MG Oral TabletSCD4b8ad98e-de76-4f49-3b89-01e9dd5cde1620
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4b8ad98e-de76-4f49-3b89-01e9dd5cde1620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63981-393-03639810393031 BOTTLE, PLASTIC in 1 PACKAGE (63981-393-03) > 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00YesNoCurrent
63981-393-1463981039314500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63981-393-14) 1999-03-010000-00-00NoNoCurrent
63981-393-5863981039358750 in 1 BOTTLE, PLASTICHistorical