FDA.reportPublic FDA data

Ibuprofen

Product NDC
55319-750
Requested package NDC
55319-750-20
11-digit product format
553190750
Labeler code
55319
Product ID
55319-750_03988cac-5ecc-4a68-a5c3-746c4ac57969
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA206999
Marketing category
ANDA
Marketing start
2018-07-31
Marketing end
2025-07-31
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 packagepackage55319-75055319-750-20DDiscontinued 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
A206999-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21

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 22:54:322026-06A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21a50c72e98297…

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENRite Aid Corporation47657d95-4a54-49c2-8273-86b413b8f41e2025-07-30WarningsExact identifier
application applno (ANDA): 206999
application number: ANDA206999
Dolex FlexIBUPROFENPharmadel LLC822d9def-504c-9beb-e053-2991aa0a280e2023-09-13WarningsExact identifier
application applno (ANDA): 206999
application number: ANDA206999
IbuprofenIBUPROFENCostco Wholesaleeb62ed66-cafd-4d09-acc9-b9abf748ba852022-10-11WarningsExact identifier
application applno (ANDA): 206999
application number: ANDA206999

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-750-202022-10-31C16284748780-1d6a99b39-bbe3-a426-e053-dadaa90af4c2Drug Facts
55319-750-302022-10-31C16284748780-1d6a99b39-bbe3-a426-e053-dadaa90af4c2Drug Facts
55319-750-802022-10-31C16284748780-1d6a99b39-bbe3-a426-e053-dadaa90af4c2Drug Facts
55319-750-202022-01-28C16284748780-1d6a99b39-bbe3-a426-e053-dadaa90af4c2Drug Facts
55319-750-302022-01-28C16284748780-1d6a99b39-bbe3-a426-e053-dadaa90af4c2Drug Facts
55319-750-802022-01-28C16284748780-1d6a99b39-bbe3-a426-e053-dadaa90af4c2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-750IBUPROFEN CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]4Legacy NDC20221101_e547d525-a5c7-4f83-9006-2e147438365b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-750-20553190750201 BOTTLE, PLASTIC in 1 BOX (55319-750-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-07-312025-07-31NoNoCurrent