FDA.reportPublic FDA data

Leader Ibuprofen PM

Product NDC
70000-0157
11-digit product format
700000157
Labeler code
70000
Product ID
70000-0157_3987ffc4-5b9d-465e-a269-5dadb8ce95b2
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA079113
Marketing category
ANDA
Marketing start
2016-11-23
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-015770000-0157-2DDiscontinued by firm2026-07-31

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
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
ndc (product): 70000-0157
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
Leader 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
b19ad305-4464-4404-a011-584fa0c08521Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0157-1Leader Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17
70000-0157-1Leader Ibuprofen PM40 in 1 BOTTLETABLET, FILM COATED407
70000-0157-2Leader Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17
70000-0157-2Leader Ibuprofen PM80 in 1 BOTTLETABLET, FILM COATED807
70000-0157-3Leader Ibuprofen PM20 in 1 BOTTLETABLET, FILM COATED207
70000-0157-3Leader Ibuprofen PM1 in 1 CARTONTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0157-1EA - Each70000-01571ddd84c2-7fb7-4369-a66b-4dc046dbc74112019-01-24
70000-0157-3EA - Each70000-0157a0ee9fce-5695-4451-ad67-26da309e79f712025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0157LEADER IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]7Current NDC, Legacy NDC, 6 package rows20241122_b19ad305-4464-4404-a011-584fa0c08521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNb19ad305-4464-4404-a011-584fa0c085217
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDb19ad305-4464-4404-a011-584fa0c085217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0157-1700000157011 BOTTLE in 1 CARTON (70000-0157-1) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-11-230000-00-00NoNoCurrent
70000-0157-2700000157021 BOTTLE in 1 CARTON (70000-0157-2) > 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-11-230000-00-00NoNoCurrent
70000-0157-3700000157031 BOTTLE in 1 CARTON (70000-0157-3) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-11-21NoNoCurrent