FDA.reportPublic FDA data

NDC 0591-0791-01 - 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
0591-0791
Requested NDC
0591-0791-01
Package NDCs from labels
0591-0791-01, 0591-0791-05
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
0591-0791-01Naproxen100 in 1 BOTTLETABLET1001
0591-0791-05Naproxen500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0791NAPROXEN (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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.71d4a048-ca50-73db-e053-2a95a90ad4652024-06-10WarningsExact identifier
rxcui: 198013
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.69366b55-2687-17a4-e053-2a91aa0a65b32024-06-07Exact identifier
rxcui: 198014
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLC1431b769-5535-78d6-e063-6394a90a84232024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENAsclemed USA, Inc.5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b2024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENMedsource Pharmaceuticals12648efc-3be8-a915-e063-6394a90a36202024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENBryant Ranch Prepack1cdcaba5-5550-40f6-94cc-b0a98cc17d3c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENBryant Ranch Prepackd564f52d-171c-4e7d-974c-3a0e192e6c122024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutionsf91c1a6b-b256-42e1-9da0-5f1975dec6ce2023-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutionsa8b54258-84e7-41e8-9e51-137a3f442e6b2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutions80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba42023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
NaproxenNAPROXENA-S Medication Solutions50c52976-9e04-4a5e-9f21-aca3ea5c29242023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutionsd801ba16-e2ec-4bb2-8cff-32388634b35a2023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENA-S Medication Solutions21930f73-d3c2-4462-a487-74ed871b74b22023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
NaproxenNAPROXENA-S Medication Solutionsa5ea3a84-7acd-4f24-9f0f-9f871ce1b5f42023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
naproxenNAPROXENCipla USA Inc.a9549a47-3fa4-4a2b-95ac-b00e43aedae72023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
NaproxenNAPROXENProficient Rx LPd0670241-f1f9-4fdf-83d4-547e7b8008112022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NAPROXENNAPROXENAsclemed USA, Inc.a4fcb411-c918-459b-adc6-06dfa8ed8a502022-10-12WarningsExact identifier
rxcui: 198014
NaproxenNAPROXENProficient Rx LPaa4d159c-9cbe-4d29-9532-33a312f1ae052022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
NaproxenNAPROXENProficient Rx LP96601d76-50ea-4dc0-b588-d174f8d8bb512022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC98efdeb8-ea38-456e-953f-ba589727f2842021-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014

Reported adverse events (FAERS/openFDA)#

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