FDA.reportPublic FDA data

NDC 50090-0481-01 - 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
50090-0481
Requested NDC
50090-0481-01
Package NDCs from labels
50090-0481-0, 50090-0481-7, 50090-0481-4, 50090-0481-5, 50090-0481-1, 50090-0481-9, 50090-0481-2, 50090-0481-6, 50090-0481-01
Manufacturer
A-S Medication Solutions
Effective date
2026-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - A-S Medication SolutionsA-S Medication Solutions2026-01-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0481-02023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-12023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-22023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-42023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-52023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-62023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-72023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-92023-02-07These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-02023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-12023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-22023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-42023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-52023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-62023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-72023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976
50090-0481-92023-01-30These highlights do not include all the information needed to use NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS. NAPROXEN TABLETS and NAPROXEN SODIUM TABLETS for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0481-0Naproxen15 in 1 BOTTLETABLET1531
50090-0481-1Naproxen20 in 1 BOTTLETABLET2031
50090-0481-2Naproxen30 in 1 BOTTLETABLET3031
50090-0481-4Naproxen14 in 1 BOTTLETABLET1431
50090-0481-5Naproxen40 in 1 BOTTLETABLET4031
50090-0481-6Naproxen100 in 1 BOTTLETABLET10031
50090-0481-7Naproxen60 in 1 BOTTLETABLET6031
50090-0481-9Naproxen6 in 1 BOTTLETABLET631

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0481NAPROXEN TABLET [A-S MEDICATION SOLUTIONS]29Current NDC, Legacy NDC, 8 package rows20240905_000155a8-709c-44e5-a75f-cd890f3a7caf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0481-0EA - Each50090-0481b73d0457-aa5d-44d1-9ffe-8e84bc4b53d512018-09-05
50090-0481-1EA - Each50090-04818d86527d-2599-4a30-82a6-c2dbd1b9872212018-09-05
50090-0481-2EA - Each50090-0481d92301e9-5ae9-43b2-b86b-e58dad9eaea912018-09-05
50090-0481-4EA - Each50090-04811442acf3-7793-4a96-8ebf-f200f2e60bce12018-09-05
50090-0481-5EA - Each50090-0481bac00d6f-6aa6-473b-a517-2d181646cda112018-09-05
50090-0481-6EA - Each50090-04813c8620e3-6f7e-46f4-a0de-5ad10fba1c2112018-09-05
50090-0481-7EA - Each50090-048133b2100d-a17f-4f6d-bad0-120a73bada7212018-09-05
50090-0481-9EA - Each50090-048108fbf0d0-348d-48a8-b1a1-760f87e6064312018-09-05

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 7 of 28 · 554 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Naproxen SodiumNAPROXEN SODIUMBetter Living Brands, LLC3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c0412026-02-13WarningsExact identifier
unii: 9TN87S3A3C
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC369911ea-9069-9c45-e063-6394a90a5ce62026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC36996557-3227-b753-e063-6394a90a7b6f2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C
naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMH E B4281faf5-7182-404f-9f53-3d9ea0354a182026-02-12WarningsExact identifier
unii: 9TN87S3A3C
Topcare All Day Pain ReliefNAPROXEN SODIUMTopco Associates LLC7f1cda40-9a67-4de1-af56-ab881c6354c42026-02-11WarningsExact identifier
unii: 9TN87S3A3C
naproxen sodiumNAPROXEN SODIUMH E B2f9439bb-e808-4c54-ba61-f75f117c8b372026-02-11WarningsExact identifier
unii: 9TN87S3A3C
Back and Muscle PainNAPROXEN SODIUMRite Aid Corporatione162bd50-f94a-4c76-8f1b-62114f2838092026-02-11WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMPadagis Israel Pharmaceuticals Ltdcdb60f74-ce23-4015-90eb-b23a2275f6cb2026-02-11WarningsExact identifier
unii: 9TN87S3A3C
Naproxen sodiumNAPROXEN SODIUMA-S Medication Solutions8181bb7a-d917-4388-bcb0-a74671b07b062026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack83dd8829-7ba0-4a8d-a979-41a5e077c49f2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C
topcare back and muscle painNAPROXEN SODIUMTopco Associates LLCde587e8f-38f2-4e7a-8e6a-64e48f280c4f2026-02-07WarningsExact identifier
unii: 9TN87S3A3C
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
Naproxen SodiumNAPROXEN SODIUMMeijer Distribution Incdb87d1da-8507-4bbf-aefc-3dbd48cde26b2026-02-05WarningsExact identifier
unii: 9TN87S3A3C
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC4a05ca8c-1b03-fa86-e063-6394a90a41192026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C

Reported adverse events (FAERS/openFDA)#

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