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 3 of 28 · 554 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENHAWAII REPACK, INC.888efc91-b4de-4691-b84c-fb871e7a6dfe2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENSt. Mary's Medical Park Pharmacye3a3e5d2-2d1e-74d3-e053-2995a90a82bf2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Naproxen SodiumNAPROXEN SODIUMLidl US LLC3d01220c-c5ec-4604-8cef-9ecb807ccd532026-06-22WarningsExact identifier
unii: 9TN87S3A3C
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
Naproxen SodiumNAPROXEN SODIUMRite Aid Corporation134e5ec6-c42a-43b6-adf2-2d7546875ead2026-06-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen Headache PainNAPROXEN SODIUML.N.K. International, Inc.6161b881-f422-47ae-86ba-a28d669bce792026-06-18WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENCoupler LLC545fe39a-4777-b149-e063-6394a90a53cf2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198013
unii: 57Y76R9ATQ
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUSNAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEVESPYR BRANDS LLCa973cb82-1e00-4706-8b96-648135ea48a12026-06-15WarningsExact identifier
unii: 9TN87S3A3C
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
NaproxenNAPROXENCoupler LLC53e6519a-cb52-85e2-e063-6394a90abdcf2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENREMEDYREPACK INC.ccd95dfc-9236-4707-a715-6a12c91519ff2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENST. MARY'S MEDICAL PARK PHARMACYe3a4ab4a-b109-eb5e-e053-2a95a90afddd2026-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXEN SODIUMFamily Dollar Services Incd9c63e1f-c2ad-434b-8a21-7fff21b7477b2026-06-03WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENA-S Medication Solutionsc5c8b6fd-f3f5-4fed-823c-9a80386b27b12026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
Mucinex 12HR Cold and Fever Multi-SymptomNAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC49f1f415-8017-0974-e063-6294a90a89182026-06-02WarningsExact identifier
unii: 9TN87S3A3C
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMDoc Rx733a93ff-8240-4afa-ba28-b0a6f8514efe2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENCoupler LLC52b8e52e-73be-3423-e063-6294a90af6e02026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198014
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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