FDA.reportPublic FDA data

basic care ibuprofen

Product NDC
72288-131
11-digit product format
722880131
Labeler code
72288
Product ID
72288-131_b7b7cef8-958a-4965-a8c1-15a1f50aa50b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA203599
Marketing category
ANDA
Marketing start
2020-07-22
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
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
A203599-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07

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 22:54:322026-06A203599-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-09-07a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health ibuprofenIBUPROFENDolgencorp Inc74f46147-b4c2-4bb3-bd0a-220c0a5403a62025-04-01WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
good sense ibuprofenIBUPROFENL. Perrigo Company0cb4b0ef-5cdd-4c79-8718-4fb157a2c9482025-03-29WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
good sense ibuprofenIBUPROFENL. Perrigo Company3b78c004-e4fe-449c-86e9-52e8ccf127852025-03-25WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
basic care ibuprofenIBUPROFENAmazon.com Services LLC25bc5cc2-9b6a-47e4-8b3d-2bb370907b612025-03-20WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
basic care ibuprofenIBUPROFENAmazon.com Services LLCcd15159a-9ed5-453a-9ad4-0c9688204c822025-03-19WarningsExact identifier
application applno (ANDA): 203599
application number: ANDA203599
ndc (product): 72288-131

Additional Listing Data#

Finished product
Yes
Brand name base
basic care ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310964Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd15159a-9ed5-453a-9ad4-0c9688204c82Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
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
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-131-06basic care ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED14
72288-131-06basic care ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-131BASIC CARE IBUPROFEN (IBUPROFEN) CAPSULE, LIQUID FILLED [AMAZON.COM SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20250322_cd15159a-9ed5-453a-9ad4-0c9688204c82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNcd15159a-9ed5-453a-9ad4-0c9688204c824
310964ibuprofen 200 MG Oral CapsuleSCDcd15159a-9ed5-453a-9ad4-0c9688204c824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-131-06722880131061 BOTTLE in 1 CARTON (72288-131-06) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent