FDA.reportPublic FDA data

NDC 50090-0481-07 - 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
50090-0481-07
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, 50090-0481-07
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 2 of 28 · 554 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.24d44eb6-921e-4150-a6b2-81f42ced32ab2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Good Sense Naproxen SodiumNAPROXEN SODIUMPreferred Pharmaceuticals Inc.2183df53-ac90-4d43-8a5d-8421036bc4cb2026-07-28WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENPreferred Pharmaceuticals Inc.49a00870-f580-4eb9-a95d-48fa956f147f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals, Inc.9f026fd5-f996-4383-b528-841d38d3dab52026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXEN SODIUMPreferred Pharmaceuticals, Inc.20eb9d9f-11df-464f-a1b0-949f8fda40422026-07-28WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENPreferred Pharmaceuticals Inc.c5e52ddd-a909-487a-bb46-01ad356906652026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.d2b1eedb-2be0-42af-ba0b-9da98560c91e2026-07-24WarningsExact identifier
unii: 9TN87S3A3C
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.65b892f2-8385-4bb0-8121-a58b01e8d13d2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Back and Muscle PainNAPROXEN SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4039504c-e612-4503-854a-62ee067809562026-07-13WarningsExact identifier
unii: 9TN87S3A3C
naproxen sodiumNAPROXEN SODIUMH E Bb5dcf3df-2628-49c7-9d96-64886bebe6312026-07-13WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)c28c4fd2-1428-421c-b62f-265e472d833e2026-07-09WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMScieGen Pharmaceuticals, Inc.79f48c92-783d-40f2-9865-89958a9f9de62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
rxcui: 849398
unii: 9TN87S3A3C
naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMMeijer Distribution Inc34d635f8-9703-4c29-92a5-85d3b47c4c932026-07-07WarningsExact identifier
unii: 9TN87S3A3C
Aleve CapletsNAPROXEN SODIUMSelect Consumer Group3ca84972-f8c9-1881-e063-6294a90a90702026-07-03WarningsExact identifier
unii: 9TN87S3A3C
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LPcfd4ef00-cfc4-4794-99fe-faa45eb2f6172026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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