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 4 of 28 · 554 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.c5146d73-2f34-4dfe-ac29-97071279dc4d2026-05-26WarningsExact identifier
unii: 9TN87S3A3C
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Berkley and Jensen Naproxen SodiumNAPROXEN SODIUMBJWC9530b649-3e01-452c-99a6-cff47fa4085b2026-05-21WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENRedpharm Drug52503536-593e-808b-e063-6294a90a737f2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMST. MARY'S MEDICAL PARK PHARMACY181c2d5b-2c61-bf20-e063-6294a90a3f7f2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C
NaproxenNAPROXENBryant Ranch Prepack0041b483-34db-49a6-8665-f87e286cd0b82026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack2e72de28-e62b-44e0-b17d-500d13e0bcc62026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepackbbc61c0a-491a-4f50-a7bf-2ca94c7715682026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMRite Aid Corporatione6277515-c606-4535-9c29-08cade045aee2026-05-14WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMCVS Pharmacyc194124b-a5f6-423e-bc9a-7b611df990a82026-05-13WarningsExact identifier
unii: 9TN87S3A3C
naproxen sodiumNAPROXEN SODIUMBionpharma Inc.9343c79f-9994-4599-bcfe-0a93e49d726e2026-05-12WarningsExact identifier
unii: 9TN87S3A3C
Mucinex DS 12HR COLD, FEVER and SINUSNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLC4e7e6674-c1ce-ea61-e063-6294a90afe042026-05-12WarningsExact identifier
unii: 9TN87S3A3C
good sense naproxen sodiumDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUML. Perrigo Companyf548aa3d-b35e-458a-9815-3595a451ab782026-05-11WarningsExact identifier
unii: 9TN87S3A3C
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company8e150c00-8e5b-40b4-a964-cb70442c27522026-05-11WarningsExact identifier
unii: 9TN87S3A3C
equaline naproxen sodiumNAPROXEN SODIUMUnited Natural Foods, Inc. dba UNFI89c02e55-fa08-4001-96fc-8a01e7e74d5a2026-05-06WarningsExact identifier
unii: 9TN87S3A3C
all day reliefNAPROXEN SODIUMPublix Super Markets Inc0f8843be-50a3-442c-9016-d9da3b444f602026-05-06WarningsExact identifier
unii: 9TN87S3A3C
rugby all day reliefNAPROXEN SODIUMRugby Laboratoriesf587a428-291c-4c54-80fe-244a961b05212026-05-06WarningsExact identifier
unii: 9TN87S3A3C
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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