FDA.reportPublic FDA data

NDC 0591-0821 - 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
0591-0821
Package NDCs from labels
0591-0821-01
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
0591-0821-01Naproxen100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0821NAPROXEN (NAPROXEN) TABLET [WATSON LABS]11 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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENBryant Ranch Prepack97d6c4ef-13b1-4b0b-a15a-f0590019940d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENBryant Ranch Prepack852fed15-e78b-47a8-aeb4-623dfe1edad92026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENREMEDYREPACK INC.6bb65680-76ea-46e5-ae70-f3091e3603682026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENREMEDYREPACK INC.12202ef3-c65e-45a6-88ed-5d945d8fd41c2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENRadha Pharmaceuticals, Inc.1a2b9a82-5b79-45ee-94ed-7a6f8c8b51702026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENAvPAKe6fbf8f1-b064-658d-17bb-e7d6320aa45f2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENScieGen Pharmaceuticals, Inc.81e22c1f-f94d-46e9-8b7d-72dc2518319e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENNuCare Pharmaceuticals,Inc.c136cf75-4ad4-8634-e053-2a95a90a53a42026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutions4e97e645-552d-424b-990a-f94349a86f172026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutions000155a8-709c-44e5-a75f-cd890f3a7caf2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutionsd06db628-f6f0-48e2-b538-69c0837c49e32026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198012
NaproxenNAPROXENA-S Medication Solutions9d28422f-6f25-4f14-9272-e0907c971f332026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198012
NaproxenNAPROXENPreferred Pharmaceuticals Inc.87acd650-ea8a-4396-be72-5568c4b1755c2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.fa2fe6fd-c476-dd29-e053-6294a90a9e9e2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENNorthwind Health Company, LLC0de6d673-fa76-e9c0-e063-6394a90a9ded2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NAPROXENNAPROXENNorthwind Health Company, LLCf32d755e-4984-ee40-e053-2995a90a4ebe2026-01-01WarningsExact identifier
rxcui: 198014
NaproxenNAPROXENNorthwind Health Company, LLCfb07a76b-98ce-85dd-e053-6294a90aa6a82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENNorthwind Health Company, LLCab6ec2c9-5df9-346c-e053-2a95a90ac81d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENNorthwind Health Company, LLCdb478961-d984-7c8e-e053-2995a90a8a122026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENNorthwind Health Company, LLCc986ba9a-6f48-8347-e053-2a95a90aa1c12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014

Reported adverse events (FAERS/openFDA)#

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