ADVIL

Product NDC
52904-794
11-digit product format
529040794
Labeler code
52904
Product ID
52904-794_41e5bb25-a17b-45b4-9da9-51b262eb2142
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Wyeth Pharmaceuticals Company
Application
NDA018989
Marketing category
NDA
Marketing start
1984-05-18
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52904-794IInactivated by FDA2026-08-10
excluded packagepackage52904-79452904-794-01IInactivated by FDA2026-08-10
excluded packagepackage52904-79452904-794-02IInactivated by FDA2026-08-10
excluded packagepackage52904-79452904-794-05IInactivated by FDA2026-08-10
excluded packagepackage52904-79452904-794-06IInactivated by FDA2026-08-10

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 2 · 95 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-794-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-794-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-794-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-794-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-794-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-794-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-794-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-794-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-794-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-794-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-794-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-794-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-794-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-794-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-794-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-794-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-794-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-794-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-794-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-794-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-794-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-794-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-794-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-794-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-794-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-794-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-794-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-794-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-794-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-794-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-794-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-794-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-794-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-794-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-794-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-794-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-794-06ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-794-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-794-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-794-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-794-06367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-794-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-794-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-794-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-794-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-794-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-794-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-794-02557ba5c1ecfa…9c80585c8c6e…

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
N018989-001ADVILIBUPROFEN200MGTABLET / ORALRLD, RS1984-05-18

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018989-001ADVIL200MGTABLET / ORAL1984-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018989-001ADVIL200MGTABLET / ORAL1984-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09N018989-001ADVIL200MGTABLET / ORAL1984-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N018989-001ADVIL200MGTABLET / ORAL1984-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-794-01ADVIL1 in 1 BLISTER PACKTABLET, COATED13
52904-794-01ADVIL2 in 1 POUCHTABLET, COATED23
52904-794-02ADVIL2 in 1 BLISTER PACKTABLET, COATED23
52904-794-02ADVIL2 in 1 POUCHTABLET, COATED23
52904-794-05ADVIL2 in 1 POUCHTABLET, COATED23
52904-794-05ADVIL1 in 1 CARTONTABLET, COATED13
52904-794-06ADVIL2 in 1 POUCHTABLET, COATED23
52904-794-06ADVIL2 in 1 CARTONTABLET, COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-794ADVIL (IBUPROFEN) TABLET, COATED [WYETH PHARMACEUTICALS COMPANY]3Legacy NDC, 8 package rows20190530_f55d1c51-67ec-459c-b120-b563b97c71ff.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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVILIBUPROFENSelect Consumer Group3ca752d8-957c-21b4-e063-6294a90a52852026-07-03WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
AdvilIBUPROFENNavajo Manufacturing Company Inc.4a64522f-b7d8-47f7-bf07-c9e8f10864252026-04-08WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
ADVILIBUPROFENHaleon US Holdings LLC1a665e64-9f30-be37-4a83-38789f1f1e892026-03-12WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
AdvilIBUPROFENJC World Bell Wholesale Co., Inc.0b83c9ed-3630-4c5c-9020-cf38183a65002025-06-27WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
AdvilIBUPROFENLil' Drug Store Products, Inc.772360bd-8631-4d24-b4db-5a7e6e1d9a132025-01-27WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
AdvilIBUPROFEN TABLETS, COATEDLil' Drug Store Products, Inc.dd302e18-39e9-7e1a-e053-2a95a90a5f7c2024-07-17WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSNf55d1c51-67ec-459c-b120-b563b97c71ff3
310965ibuprofen 200 MG Oral TabletPSNf55d1c51-67ec-459c-b120-b563b97c71ff3
153008ibuprofen 200 MG Oral Tablet [Advil]SBDf55d1c51-67ec-459c-b120-b563b97c71ff3
310965ibuprofen 200 MG Oral TabletSCDf55d1c51-67ec-459c-b120-b563b97c71ff3
153008Advil 200 MG Oral TabletSYf55d1c51-67ec-459c-b120-b563b97c71ff3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf55d1c51-67ec-459c-b120-b563b97c71ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52904-794-01529040794011 in 1 BLISTER PACKHistorical
52904-794-02529040794022 in 1 BLISTER PACKHistorical
52904-794-05529040794052 in 1 POUCHHistorical
52904-794-06529040794062 in 1 POUCHHistorical