FDA.reportPublic FDA data

Topcare Ibuprofen PM

Product NDC
36800-050
11-digit product format
368000050
Labeler code
36800
Product ID
36800-050_ce7b2954-4165-4ca8-902d-8349eea450be
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate and ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-02-18
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
Listing certified through
2026-12-31
Current FDA listing
Yes

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079113-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2008-12-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 36800-050
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

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Ibuprofen PM
Listing expiration
2026-12-31

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
1435e627-144e-4dc8-9ad6-58d91cbd9094Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-050-27Topcare Ibuprofen PM80 in 1 BOTTLETABLET, FILM COATED808
36800-050-27Topcare Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED18
36800-050-58Topcare Ibuprofen PM40 in 1 BOTTLETABLET, FILM COATED408
36800-050-58Topcare Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED18
36800-050-60Topcare Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED18
36800-050-60Topcare Ibuprofen PM20 in 1 BOTTLETABLET, FILM COATED208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-050-27EA - Each36800-05008f4bd29-cc8a-4737-9f3e-d9df8bbca1fa12012-07-24
36800-050-58EA - Each36800-0508abf46de-01f9-48c6-95fd-878cb99ad62a12012-07-24
36800-050-60EA - Each36800-05095db4c8d-81d8-4f0b-aa79-ba6878d4b28412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
IBUPROFENACTIVE INGREDIENTWK2XYI10QMTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
IBUPROFENACTIVE MOIETYWK2XYI10QMTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-050TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 6 package rows20250423_1435e627-144e-4dc8-9ad6-58d91cbd9094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN1435e627-144e-4dc8-9ad6-58d91cbd90948
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD1435e627-144e-4dc8-9ad6-58d91cbd90948

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-050-27368000050271 BOTTLE in 1 CARTON (36800-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-240000-00-00NoNoCurrent
36800-050-58368000050581 BOTTLE in 1 CARTON (36800-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-180000-00-00NoNoCurrent
36800-050-60368000050601 BOTTLE in 1 CARTON (36800-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-02-190000-00-00NoNoCurrent