careone ibuprofen pm

Product NDC
41520-413
Requested package NDC
41520-413-27
11-digit product format
415200413
Labeler code
41520
Product ID
41520-413_e8dd6f2e-71e7-46be-adc3-cebdf6845ad1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine citrate, Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Sales Company
Application
ANDA079113
Marketing category
ANDA
Marketing start
2011-12-08
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38 mg/1; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-41341520-413-27DDiscontinued by firm2026-08-10

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 1 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATEDIPHENHYDRAMINE CITRATE; IBUPROFEN38MG;200MGTABLET / ORAL2008-12-22

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 UTC2026-02A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
IBUPROFENACTIVE MOIETYWK2XYI10QMCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-413CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [AMERICAN SALES COMPANY]4Legacy NDC20190207_8bfbb5b5-67f5-4a87-a926-10f140353ab5.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good neighbor pharmacy ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENAmerisource Bergen2829ee62-7685-4dbb-9f61-4ee0fb19e4c62026-05-15WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENMeijer Distribution Inc47e71e23-da8a-4759-ac5a-1d48e0d9ab982026-04-22WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
Care One Ibuprofen PMDIPHENHYDRAMINE CITRATE AND IBUPROFENAmerican Sales Companyd5bf76d1-6fed-4f6b-8507-3e8973295d672026-04-01WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENRite Aid Corporationd9eefb84-cc2e-4deb-a1c0-a7c21929f5ac2026-03-27WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
up and up ibuprofen pmDIPHENHYDRAMINE CITRATE AND IBUPROFENTarget Corporation0c764683-f3c9-4382-96be-d34b7a582aee2026-03-16WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENHyVee Inc833a2bee-0e55-44f7-b80d-b336ebe52fc92026-01-14WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
IBUPROFEN PMDIPHENHYDRAMINE CITRATE, IBUPROFENSafeway57e8f0d7-1f21-4fda-8b21-3caa54fae4e62026-01-02WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
ibuprofen pmDIPHENHYDRAMINE CITRATE AND IBUPROFENCVS Pharmacy44e4e54b-cb40-4b7c-a141-181bde62a69f2025-10-24WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
Motrin PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKenvue Brands LLC55403f19-58ae-450b-8a7b-0bc544088f202025-07-11WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENKroger Company347dd263-ba0d-4a5a-8ac8-e586fcfd014e2025-06-23WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWalgreen Company9c5c1f48-d285-4faa-96d0-b04f435c9c5c2025-06-23WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENH E B2114b2a9-f9af-43b9-97ec-859a4afe7ec82025-04-21WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
good sense ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENL. Perrigo Company0488786f-9b6b-4935-bb57-bcb2565447f82025-04-21WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
Topcare Ibuprofen PMDIPHENHYDRAMINE CITRATE AND IBUPROFENTopco Associates LLC1435e627-144e-4dc8-9ad6-58d91cbd90942025-04-21WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
equaline ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENUnited Natural Foods, Inc. dba UNFI5c4ff82a-bdc4-4df5-9df7-abc6becf4f4d2025-04-21WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
Exchange Select Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENArmy & Air Force Exchange Service56761c01-48f2-4d17-a607-6639fb3a7a982025-04-21WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
equate ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENWal-Mart Stores Ince36957ed-653c-465f-8150-7d6073e1376f2025-03-16WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
Leader Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENCardinal Health 110, LLC. dba Leaderb19ad305-4464-4404-a011-584fa0c085212024-11-21WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
basic care ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENAmazon.com Services LLC6bd8bad2-4370-4450-822a-9ef50949a8fc2024-09-09WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113
dg health Ibuprofen pmDIPHENHYDRAMINE CITRATE AND IBUPROFENDolgencorp Inc4bbe40de-0957-4705-893d-fcb4191885c92024-01-22WarningsExact identifier
application applno (ANDA): 079113
application number: ANDA079113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-413-27415200413271 BOTTLE in 1 CARTON (41520-413-27) > 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-09-050000-00-00NoNoCurrent