FDA.reportPublic FDA data

NDC 85509-1202-06 - Naproxen and esomeprazole magnesium

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
85509-1202
Requested NDC
85509-1202-06
Package NDCs from labels
85509-1202-3, 85509-1202-6, 85509-1202-06
Manufacturer
PHOENIX RX LLC
Effective date
2025-07-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen and esomeprazole magnesium - PHOENIX RX LLCPHOENIX RX LLC2025-07-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1202-3Naproxen and esomeprazole magnesium30 in 1 BOTTLETABLET, DELAYED RELEASE301
85509-1202-6Naproxen and esomeprazole magnesium60 in 1 BOTTLETABLET, DELAYED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1202-3EA - Each85509-120249443837-1ea1-40cc-9727-1156af2f240812025-09-12
85509-1202-6EA - Each85509-12025d7be8d3-1020-4270-b719-11ff4233bee912025-09-12

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 58 · 1,145 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENSportpharm LLC1c5b2bc1-26bb-4f88-bded-399263c823312026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
PRENATE DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENTAvion Pharmaceuticals, LLC8f2eca71-9a82-4a19-9206-36a04b865fe12026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.2164e1d7-e601-4ce5-be29-0c21c3a5a6472026-04-16Exact identifier
unii: R6DXU4WAY9
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
NaproxenNAPROXENBryant Ranch Prepackf18181f4-6b14-48a8-a149-e45b3360a2502026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENCameron Pharmaceuticals2ae474dd-eaae-4401-8d42-613d672daea02026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
PRENATE EnhanceASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLCcf10de09-6ed5-4a66-84fa-2da4f668bbe62026-04-14Boxed warning, Adverse reactionsExact identifier
unii: 3A3U0GI71G
NaproxenNAPROXENBryant Ranch Prepack97d6c4ef-13b1-4b0b-a15a-f0590019940d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack852fed15-e78b-47a8-aeb4-623dfe1edad92026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNCS HealthCare of KY, LLC dba Vangard Labs28fbfa02-6c7b-4eb1-af24-86825e6523262026-04-14Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: ETJ7Z6XBU4
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.a9d05a38-08db-4710-b6f3-20c92ce885d52026-04-13Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsb58bfbdb-939e-456e-827d-068e9d8088402026-04-13Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions8a8ca4cf-076c-48c9-8613-f5a1bae87a492026-04-13Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
NaproxenNAPROXENREMEDYREPACK INC.6bb65680-76ea-46e5-ae70-f3091e3603682026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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