FDA.reportPublic FDA data

Ibuprofen

Product NDC
35916-0989
Requested package NDC
35916-0989-1
11-digit product format
359160989
Labeler code
35916
Product ID
35916-0989_495880e2-c219-84bd-e063-6294a90a645a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Softgel Healthcare Private Limited
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-10
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
2b07ace6-6766-0a06-e063-6294a90ad1bdAvailable 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
35916-0989-1Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED12
35916-0989-1Ibuprofen1000 in 1 BAGCAPSULE, LIQUID FILLED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-0989IBUPROFEN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED]1Current NDC, 2 package rows20250112_2b07ace6-6766-0a06-e063-6294a90ad1bd.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENSoftgel Healthcare Private Limited2b07ace6-6766-0a06-e063-6294a90ad1bd2026-01-27WarningsExact identifier
ndc (package): 35916-0989-1
ndc (product): 35916-0989
ndc11 (package): 35916098901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN2b07ace6-6766-0a06-e063-6294a90ad1bd2
310964ibuprofen 200 MG Oral CapsuleSCD2b07ace6-6766-0a06-e063-6294a90ad1bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35916-0989-1359160989011 BAG in 1 BOX (35916-0989-1) / 1000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2025-01-10NoNoCurrent