Clear Choice Ibuprofen

Product NDC
53185-003
11-digit product format
531850003
Labeler code
53185
Product ID
53185-003_40b9968a-8fd9-5ed9-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Athlete's Needs Inc
Application
ANDA079129
Marketing category
ANDA
Marketing start
2012-10-09
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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
53185-003-002020-01-31C16284748780-19d75b9d0-8ea8-f424-e053-dadaa90a57ceClear Choice Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53185-003-00Clear Choice Ibuprofen100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
IBUPROFENACTIVE MOIETYWK2XYI10QMCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53185-003CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]2Legacy NDC, 1 package rows20161107_20bde9bd-7b13-4be4-9cba-ebc10c834a7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN20bde9bd-7b13-4be4-9cba-ebc10c834a7a2
310965ibuprofen 200 MG Oral TabletSCD20bde9bd-7b13-4be4-9cba-ebc10c834a7a2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY20bde9bd-7b13-4be4-9cba-ebc10c834a7a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53185-003-0053185000300100 in 1 BOTTLEHistorical