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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENPreferred Pharmaceuticals Inc.727913f6-9542-4a2d-9318-4b7ff521bffd2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENAmneal Pharmaceuticals of New York LLC2718e0b7-1ce6-457e-bee9-11b634dfd3532025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENDirect_Rxf499a207-02c8-a338-e053-2995a90accc02025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NAPROXENNAPROXENDIRECT RXb1b78c49-82e9-2402-e053-2a95a90ae35f2025-01-17WarningsExact identifier
rxcui: 198014
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ad850-57b5-a21d-e053-2a95a90ae68e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a94a8-3825-eabd-e053-2a95a90acd582024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a96cf-1cda-8ace-e053-2a95a90a18cc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ac948-4405-5abf-e053-2995a90af2b52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9aa7a0-e287-5935-e053-2995a90a1d112024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLCd292f376-1844-b01c-e053-2a95a90a09272024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENQuality Care Products, LLC1acfb8cc-6faf-4b3e-9304-4819c42de0a62024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaprotinNAPROXEN , CAPSAICINPureTek Corporationdc2d2783-2a73-cb7c-e053-2995a90a99612024-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENMARKSANS PHARMA LIMITED1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c82024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENBryant Ranch Prepackda61463f-f87b-4aba-b538-7264252cadb82024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
NaproxenNAPROXENBryant Ranch Prepack1fe9a6fc-940e-4a18-b3e9-b204fd67f2632024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENBoswell Pharmacy Services LLC d/b/a BPS Wholesale205b1159-06e5-0d48-e063-6294a90acbd82024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENBryant Ranch Prepacka4f31070-4ee1-4d64-8b1d-40b9011e124b2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENNuCare Pharmaceuticals, Inc.46dd3908-6feb-4f50-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENNuCare Pharmaceuticals, Inc.3e8bcc59-dab1-1b4c-e054-00144ff88e882024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.5487dee2-5c37-4348-e054-00144ff8d46c2024-07-17WarningsExact identifier
rxcui: 198014

Reported adverse events (FAERS/openFDA)#

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