FDA.reportPublic FDA data

NDC 50090-5646-01 - 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
50090-5646
Requested NDC
50090-5646-01
Package NDCs from labels
50090-5646-1, 50090-5646-2, 50090-5646-01
Manufacturer
A-S Medication Solutions
Effective date
2025-10-08
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 Solutions2025-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5646-1Naproxen90 in 1 BOTTLETABLET902
50090-5646-2Naproxen180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5646-1EA - Each50090-5646cfdcde3e-2e6b-4c13-ade7-3e44445b1a0b12025-12-16
50090-5646-2EA - Each50090-56462db5f636-d3f1-4613-a6b2-d8feba39030312025-12-16

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 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENQuality Care Products, LLC1acfb8cc-6faf-4b3e-9304-4819c42de0a62024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENHikma Pharmaceuticals USA Inc.a5757b1a-62c9-4421-9794-6fb121ce9b7e2024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaprotinNAPROXEN , CAPSAICINPureTek Corporationdc2d2783-2a73-cb7c-e053-2995a90a99612024-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
NaproxenNAPROXENAmneal Pharmaceuticals NY LLC985aedc1-8b3c-4cb4-af13-7203a2b57ab72024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENMARKSANS PHARMA LIMITED1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c82024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENBryant Ranch Prepackda61463f-f87b-4aba-b538-7264252cadb82024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack1fe9a6fc-940e-4a18-b3e9-b204fd67f2632024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBoswell Pharmacy Services LLC d/b/a BPS Wholesale205b1159-06e5-0d48-e063-6294a90acbd82024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepacka4f31070-4ee1-4d64-8b1d-40b9011e124b2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals,Inc.5e873524-f9fb-fe2d-e053-2991aa0aa0a52024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals, Inc.46dd3908-6feb-4f50-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENNuCare Pharmaceuticals, Inc.3e8bcc59-dab1-1b4c-e054-00144ff88e882024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.5487dee2-5c37-4348-e054-00144ff8d46c2024-07-17WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.71d4a048-ca50-73db-e053-2a95a90ad4652024-06-10WarningsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.69366b55-2687-17a4-e053-2a91aa0a65b32024-06-07Exact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack74134b90-d4c7-41bd-a1bd-2ac168db596f2024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLC1431b769-5535-78d6-e063-6394a90a84232024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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