FDA.reportPublic FDA data

NDC 0591-0822 - Naproxen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0591-0822
Package NDCs from labels
0591-0822-01, 0591-0822-05
Manufacturer
Watson Labs
Effective date
2007-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - Watson LabsWatson Labs2007-02-06HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0822-01Naproxen100 in 1 BOTTLETABLET1001
0591-0822-05Naproxen500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0822NAPROXEN (NAPROXEN) TABLET [WATSON LABS]12 package rows20070712_AF3CA49D-65E0-47BC-A2E6-A38277DB9408.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NaproxenACTIVE INGREDIENT57Y76R9ATQNAPROXEN (NAPROXEN) TABLET [WATSON LABS]1
NaproxenACTIVE MOIETY57Y76R9ATQNAPROXEN (NAPROXEN) TABLET [WATSON LABS]1
Croscarmellose sodiumINACTIVE INGREDIENTNAPROXEN (NAPROXEN) TABLET [WATSON LABS]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30NAPROXEN (NAPROXEN) TABLET [WATSON LABS]1
PovidoneINACTIVE INGREDIENTNAPROXEN (NAPROXEN) TABLET [WATSON LABS]1
Synthetic black iron oxideINACTIVE INGREDIENTNAPROXEN (NAPROXEN) TABLET [WATSON LABS]1
Synthetic red iron oxideINACTIVE INGREDIENTNAPROXEN (NAPROXEN) TABLET [WATSON LABS]1
Synthetic yellow iron oxideINACTIVE INGREDIENTNAPROXEN (NAPROXEN) TABLET [WATSON LABS]1

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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC9c963e77-6e05-47d0-a8d3-e581777377b92021-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
rxcui: 198012
NAPROXENNAPROXENAphena Pharma Solutions - Tennessee, LLC32693390-763b-46dd-b821-65a7bf3c66712021-04-26WarningsExact identifier
rxcui: 198014
NaproxenNAPROXENProficient Rx LPfc3ee94a-adb7-411e-a662-2f2c6ddbabaf2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENProficient Rx LP3e4e5371-d796-47c7-95c1-d99e82a0b2822021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC3e14f839-d1e4-44df-a457-29f005b3e62e2020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NAPROXENNAPROXENBryant Ranch Prepack5d399bf3-db49-411a-91b9-b410d702a65a2020-12-14WarningsExact identifier
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENExelan Pharmaceuticals, Inc.46dbdb95-a0d0-4410-8d64-b22763b12af72020-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NAPROXENNAPROXENTIME CAP LABORATORIES4350a2d9-5228-460e-b7b1-27e8fa8467872018-10-09WarningsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLCe2347581-90da-429a-b17c-cffd0039fb862017-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENNCS HealthCare of KY, Inc dba Vangard Labs62a12771-bde9-4bc3-9ce9-672c8e31f0202017-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
3BB032FE-E776-C7C1-DB24-103F409F7ED4AF3CA49D-65E0-47BC-A2E6-A38277DB94082007-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 3BB032FE-E776-C7C1-DB24-103F409F7ED4
spl set id: AF3CA49D-65E0-47BC-A2E6-A38277DB9408

Reported adverse events (FAERS/openFDA)#

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