ibuprofen pm

Product NDC
11822-0050
11-digit product format
118220050
Labeler code
11822
Product ID
11822-0050_4b815346-969e-4f5a-af95-09d3c984b36c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Citrate, Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-03-19
Marketing end
2026-10-31
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-005011822-0050-2DDiscontinued by firm2026-08-17
excluded packagepackage11822-005011822-0050-4DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0511822-0050-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511822-0050-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2611822-0050-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611822-0050-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3111822-0050-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111822-0050-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2811822-0050-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811822-0050-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2111822-0050-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111822-0050-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1011822-0050-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011822-0050-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3111822-0050-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3111822-0050-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2011822-0050-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2011822-0050-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1011822-0050-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1011822-0050-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0811822-0050-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0811822-0050-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0311822-0050-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0311822-0050-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0911822-0050-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0911822-0050-2557ba5c1ecfa…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
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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
ibuprofen pm

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE CITRATE38 mg/1
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4OD433S209Internal UNII lookup
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
895664Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9eefb84-cc2e-4deb-a1c0-a7c21929f5acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0050-1ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED808
11822-0050-1ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18
11822-0050-2ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18
11822-0050-2ibuprofen pm40 in 1 BOTTLETABLET, FILM COATED408
11822-0050-3ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED208
11822-0050-3ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18
11822-0050-4ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18
11822-0050-4ibuprofen pm30 in 1 BOTTLETABLET, FILM COATED308
11822-0050-5ibuprofen pm1 in 1 CARTONTABLET, FILM COATED18
11822-0050-5ibuprofen pm120 in 1 BOTTLETABLET, FILM COATED1208

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0050IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [RITE AID CORPORATION]7Current NDC, Legacy NDC, 10 package rows20230928_d9eefb84-cc2e-4deb-a1c0-a7c21929f5ac.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
ndc (product): 11822-0050
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNd9eefb84-cc2e-4deb-a1c0-a7c21929f5ac8
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDd9eefb84-cc2e-4deb-a1c0-a7c21929f5ac8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0050-1118220050011 BOTTLE in 1 CARTON (11822-0050-1) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-06-242026-08-31NoNoCurrent
11822-0050-2118220050021 in 1 CARTONHistorical
11822-0050-3118220050031 BOTTLE in 1 CARTON (11822-0050-3) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-03-192026-10-31NoNoCurrent
11822-0050-4118220050041 in 1 CARTONHistorical
11822-0050-5118220050051 BOTTLE in 1 CARTON (11822-0050-5) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-08-232026-08-31NoNoHistorical