Ibuprofen and Pseudoephedrine Hydrochloride

Product NDC
11673-423
11-digit product format
116730423
Labeler code
11673
Product ID
11673-423_586f87fc-2225-43d7-b980-335d10e0069b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Target Corporation
Application
ANDA074567
Marketing category
ANDA
Marketing start
2001-10-08
Marketing end
0000-00-00
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11673-423IInactivated by FDA2026-08-03
excluded packagepackage11673-42311673-423-41IInactivated by FDA2026-08-03

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 · 42 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 packagepackage11673-423-41d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11673-423-41f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11673-423-412ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11673-423-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11673-423-41cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11673-423-41cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11673-423-41302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11673-423-41ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11673-423-410efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11673-423-41ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11673-423-41367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-423-41557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11673-423-418af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11673-423-41834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11673-423-411332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11673-423-41fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11673-423-4186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11673-423-41bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11673-423-418dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11673-423-41e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11673-423-419bebd1f3094a…5416666fcb17…

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
A074567-001IBUPROHM COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2001-04-17

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 UTC2026-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074567-001IBUPROHM COLD AND SINUS200MG;30MGTABLET / ORAL2001-04-17cb3db0bc1861…

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-423-412020-01-31C16284748780-19d75b9cf-e354-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-423-41Ibuprofen and Pseudoephedrine Hydrochloride40 in 1 BLISTER PACKTABLET, COATED401

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
ACACIAINACTIVE INGREDIENT5C5403N26OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
GUAR GUMINACTIVE INGREDIENTE89I1637KEIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
KAOLININACTIVE INGREDIENT24H4NWX5COIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
SHELLACINACTIVE INGREDIENT46N107B71OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
TRISTEARININACTIVE INGREDIENTP6OCJ2551RIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-423IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]1Legacy NDC, 1 package rows20121018_d85b2343-cea2-4cd2-bf03-efa44f6d65fb.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.65ec0f85-7ca3-4adc-b152-a0ae2fd0692f2025-02-27WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEThe Kroger Company2c15339d-a33b-4884-87d8-a3b50903a2c82024-12-27WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLCd93ae778-e6e9-4d1d-8f46-c04d962a93932024-11-22WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANYc3b302c6-a2d2-491c-8f56-ecc25dd1f6c02022-10-07WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2022-01-26WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy627ea7db-47f1-40c2-b1ca-72dc66542e4a2021-12-21WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.c0692a21-358d-47b9-bbff-cc8f4f3bdb562020-09-09WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.cb7fb0d3-adf6-4c14-ac61-103dc869ebf22020-09-09WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122018-10-23WarningsExact identifier
application applno (ANDA): 074567
application number: ANDA074567

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSNd85b2343-cea2-4cd2-bf03-efa44f6d65fb1
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCDd85b2343-cea2-4cd2-bf03-efa44f6d65fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11673-423-411167304234140 in 1 BLISTER PACKHistorical