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 8 of 28 · 554 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby All Day ReliefNAPROXEN SODIUMBryant Ranch Prepack3238dfdc-82d1-4afb-b27c-0ba0a5d247442026-02-04WarningsExact identifier
unii: 9TN87S3A3C
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: 1K09F3G675
NaproxenNAPROXENA-S Medication Solutions4e97e645-552d-424b-990a-f94349a86f172026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198014
unii: 57Y76R9ATQ
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company6bc74cda-458c-480e-a33c-d2ba68d5e6bd2026-01-29WarningsExact identifier
unii: 9TN87S3A3C
Care One Naproxen SodiumNAPROXEN SODIUMAmerican Sales Companybc5ddcf2-640c-4683-a60f-ca1c8b4188732026-01-29WarningsExact identifier
unii: 9TN87S3A3C
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
NaproxenNAPROXENA-S Medication Solutions000155a8-709c-44e5-a75f-cd890f3a7caf2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
ndc (package): 50090-0481-6
ndc (package): 50090-0481-2
ndc (package): 50090-0481-4
ndc (package): 50090-0481-0
ndc (package): 50090-0481-9
ndc (package): 50090-0481-5
ndc (package): 50090-0481-7
ndc (package): 50090-0481-1
ndc (product): 50090-0481
ndc11 (package): 50090048101
rxcui: 198014
spl id: 8c45ef1f-f708-485b-bc20-60aa87ce6289
spl set id: 000155a8-709c-44e5-a75f-cd890f3a7caf
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsd06db628-f6f0-48e2-b538-69c0837c49e32026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198014
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions9d28422f-6f25-4f14-9272-e0907c971f332026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 849431
rxcui: 198014
rxcui: 198012
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack1c2325f7-1d65-429d-a64d-6ab075df1c202026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849398
unii: 9TN87S3A3C
Flanax Menstrual Pain RelieverNAPROXEN SODIUMBelmora LLC2b4135b3-389c-46e2-ae86-7674c2ab9a322026-01-27WarningsExact identifier
unii: 9TN87S3A3C
BACK AND MUSCLE PAINNAPROXENWALGREENS81417810-8a34-c859-e053-2a91aa0a65072026-01-26WarningsExact identifier
unii: 9TN87S3A3C
Leader All Day Pain ReliefNAPROXEN SODIUMCardinal Health 110, LLC. dba Leaderdbf007f5-c792-43a7-8cc1-bfa617f3a7fa2026-01-26WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENPreferred Pharmaceuticals Inc.87acd650-ea8a-4396-be72-5568c4b1755c2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078250
rxcui: 198014
unii: 57Y76R9ATQ
naproxen sodiumNAPROXEN SODIUMMeijer Distribution Incf4e57560-ae89-4fc3-a66b-ebf3dc3f24482026-01-22WarningsExact identifier
unii: 9TN87S3A3C
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.b295a90e-320f-4414-b80a-d11f06c00c962026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a0c910-7dd7-6a42-e063-6394a90a491c2026-01-13WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a00020-173b-a4a1-e063-6294a90ae3992026-01-13WarningsExact identifier
unii: 9TN87S3A3C
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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