FDA.reportPublic FDA data

Pain Relief

Product NDC
52904-447
11-digit product format
529040447
Labeler code
52904
Product ID
52904-447_9b05aa4c-903e-43ec-a79f-ec675bc6e77a
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Select Corporation
Application
ANDA091239
Marketing category
ANDA
Marketing start
2012-10-15
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-447-022020-01-31C16284748780-19d75b9d1-1710-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-447-02Pain Relief2 in 1 PACKETTABLET21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMPAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
IBUPROFENACTIVE MOIETYWK2XYI10QMPAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQPAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-447PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]1Legacy NDC, 1 package rows20121106_87feec83-7b0a-41b5-972f-80592bab7c2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN87feec83-7b0a-41b5-972f-80592bab7c2d1
310965ibuprofen 200 MG Oral TabletSCD87feec83-7b0a-41b5-972f-80592bab7c2d1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY87feec83-7b0a-41b5-972f-80592bab7c2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52904-447-02529040447022 in 1 PACKETHistorical