TopCare Ibuprofen

Product NDC
36800-604
11-digit product format
368000604
Labeler code
36800
Product ID
36800-604_7b44c9b1-8c1d-4234-922c-9ffff0202bc5
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA072096
Marketing category
ANDA
Marketing start
1988-02-15
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-60436800-604-93DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare 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
66097f19-227c-4f9c-a7f3-ab8476e1bb6eAvailable 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
36800-604-62TopCare Ibuprofen24 in 1 BOTTLETABLET, FILM COATED2410
36800-604-62TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-71TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-71TopCare Ibuprofen50 in 1 BOTTLETABLET, FILM COATED5010
36800-604-76TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-76TopCare Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12010
36800-604-78TopCare Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10010
36800-604-78TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-82TopCare Ibuprofen2 in 1 CARTONTABLET, FILM COATED210
36800-604-82TopCare Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10010
36800-604-85TopCare Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25010
36800-604-85TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-90TopCare Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50010
36800-604-93TopCare Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-604-62EA - Each36800-60477d7c935-ed38-435f-aa5b-7a6db4a52e3412012-07-24
36800-604-71EA - Each36800-604fef9bf91-20df-460a-80a0-464b71c44c3512012-07-24
36800-604-78EA - Each36800-60438a5461b-9333-4c53-a93c-18492d43425512012-07-24
36800-604-85EA - Each36800-6041c143d48-595c-489e-9044-0847be4c311112012-07-24
36800-604-90EA - Each36800-6046ffd53ba-ceb6-48ad-9c66-efc12c97d7fd12012-07-24
36800-604-93EA - Each36800-604d646a87b-5f83-4a29-9210-f6a67a49424912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-604TOPCARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]10Current NDC, Legacy NDC, 14 package rows20250418_66097f19-227c-4f9c-a7f3-ab8476e1bb6e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen085dcc1a-e4b0-4d08-9476-72275382d1a12026-05-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNorthwind Health Company, LLCda6c2802-5d15-dbcb-e053-2a95a90a25612026-01-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENL. Perrigo Company70d0a429-27c1-43a5-b2ea-a9919e0910f82025-12-22WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.c447fc6b-e9ef-447a-9609-5f893e18dfa72025-11-17WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN66097f19-227c-4f9c-a7f3-ab8476e1bb6e10
310965ibuprofen 200 MG Oral TabletSCD66097f19-227c-4f9c-a7f3-ab8476e1bb6e10
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY66097f19-227c-4f9c-a7f3-ab8476e1bb6e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-604-62368000604621 BOTTLE in 1 CARTON (36800-604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-06-150000-00-00NoNoCurrent
36800-604-71368000604711 BOTTLE in 1 CARTON (36800-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-02-150000-00-00NoNoCurrent
36800-604-76368000604761 BOTTLE in 1 CARTON (36800-604-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle1993-09-270000-00-00NoNoCurrent
36800-604-78368000604781 BOTTLE in 1 CARTON (36800-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-03-150000-00-00NoNoCurrent
36800-604-82368000604822 BOTTLE in 1 CARTON (36800-604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle1988-02-150000-00-00NoNoCurrent
36800-604-85368000604851 BOTTLE in 1 CARTON (36800-604-85) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-07-300000-00-00NoNoCurrent
36800-604-9036800060490500 TABLET, FILM COATED in 1 BOTTLE (36800-604-90) 1993-07-290000-00-00NoNoCurrent
36800-604-93368000604931000 in 1 BOTTLEHistorical