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 3 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENQPharma, Inc.307aa67f-53b9-4c60-a328-091bbf6338d42025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
Naproxen SodiumNAPROXEN SODIUMGlenmark Pharmaceuticals Inc., USA6c5bb008-e66f-4ef0-bf84-aca7eb5983e92025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NAPROXENNAPROXENQPharma Incc0a4839b-7154-c82c-e053-2a95a90a7e6d2025-12-03WarningsExact identifier
rxcui: 198014
NaproxenNAPROXENPHOENIX RX LLC43912294-77c9-eda8-e063-6394a90adf0a2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutions8c3398bd-66b1-4a14-8aaa-e4a2d6749a082025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENMedcore LLC129392c8-8ce1-4b78-8863-042db880095f2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.a9f9ce81-9d51-4167-9581-974866a8fe312025-10-17WarningsExact identifier
rxcui: 198014
NaproxenNAPROXENBryant Ranch Prepacke0f430fd-4511-41c8-b5e9-894abe4f3c372025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutionscfa88511-40bb-4658-b606-44c68d0746b72025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutionsb500bdba-946a-41ff-855c-1f2937547d012025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.29d98cf3-a0f2-3f89-e054-00144ff88e882025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.6573681e-e9be-440f-a818-a533b744648e2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
NaproxenNAPROXENProficient Rx LPe64b3b36-f96e-463e-aca8-8f6e86724bcf2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
NaproxenNAPROXENAurobindo Pharma Limited0e5315bc-c02f-4749-be69-b5b528327d582025-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENAmneal Pharmaceuticals LLCc43a43e2-e867-448d-8f59-3efc7c077cbc2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENA-S Medication Solutions7fef9311-471b-472c-b4f2-c952a2b3a2552025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENCoupler LLC3375e139-d9de-8c2d-e063-6394a90a653d2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutionse63a034d-23ef-458f-88ed-8b6d736996212025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
NaproxenNAPROXENAsclemed USA, Inc.1e406e47-408a-48cc-921e-52882a11581c2025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENBryant Ranch Prepack9d7bc470-fbba-40a6-a56c-f681a3cee9cf2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014

Reported adverse events (FAERS/openFDA)#

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