FDA.reportPublic FDA data

Naprotin

Product NDC
59088-630
Requested package NDC
59088-630-00
11-digit product format
590880630
Labeler code
59088
Product ID
59088-630_292f7fd5-53b4-9da9-e063-6394a90a52e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen , Capsaicin
Dosage form
KIT
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-09-27
NDC exclude flag
No
Listing certified through
2026-12-31
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
Naprotin
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198014Internal RxNorm lookup
198555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc2d2783-2a73-cb7c-e053-2995a90a9961Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-436-01Naprotin100 in 1 BOTTLETABLET100500 mg2
59088-630-00Naprotin1 in 1 KITKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-630-00EA - Each59088-630597881e9-3e50-494d-bfac-01a451c5b55c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-630NAPROTIN (NAPROXEN , CAPSAICIN) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241215_dc2d2783-2a73-cb7c-e053-2995a90a9961.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
NaprotinNAPROXEN , CAPSAICINPureTek Corporationdc2d2783-2a73-cb7c-e053-2995a90a99612024-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 59088-630-00
ndc (product): 59088-630
ndc11 (package): 59088063000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSNdc2d2783-2a73-cb7c-e053-2995a90a99612
198014naproxen 500 MG Oral TabletPSNdc2d2783-2a73-cb7c-e053-2995a90a99612
198555capsaicin 0.25 MG/ML Topical CreamSCDdc2d2783-2a73-cb7c-e053-2995a90a99612
198014naproxen 500 MG Oral TabletSCDdc2d2783-2a73-cb7c-e053-2995a90a99612
198555capsaicin 0.025 % Topical CreamSYdc2d2783-2a73-cb7c-e053-2995a90a99612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-630-00590880630001 KIT in 1 KIT (59088-630-00) * 100 TABLET in 1 BOTTLE (50228-436-01) * 237 mL in 1 BOTTLE, PUMP (59088-310-16) 1 kit2022-09-270000-00-00NoNoCurrent