FDA.reportPublic FDA data

NDC 70518-3486-01 - 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
70518-3486
Requested NDC
70518-3486-01
Package NDCs from labels
70518-3486-0, 70518-3486-1, 70518-3486-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - REMEDYREPACK INC.REMEDYREPACK INC.2026-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3486-0Naproxen30 in 1 BLISTER PACKTABLET306
70518-3486-1Naproxen60 in 1 BOTTLE, PLASTICTABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3486NAPROXEN TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 2 package rows20240322_6bb65680-76ea-46e5-ae70-f3091e360368.zip

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 11 · 204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENREMEDYREPACK INC.ccd95dfc-9236-4707-a715-6a12c91519ff2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENST. MARY'S MEDICAL PARK PHARMACYe3a4ab4a-b109-eb5e-e053-2a95a90afddd2026-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsc5c8b6fd-f3f5-4fed-823c-9a80386b27b12026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
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
rxcui: 198014
unii: 57Y76R9ATQ
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENRedpharm Drug52503536-593e-808b-e063-6294a90a737f2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack0041b483-34db-49a6-8665-f87e286cd0b82026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack2e72de28-e62b-44e0-b17d-500d13e0bcc62026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepackbbc61c0a-491a-4f50-a7bf-2ca94c7715682026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198012
unii: 57Y76R9ATQ
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENSportpharm LLC1c5b2bc1-26bb-4f88-bded-399263c823312026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepackf18181f4-6b14-48a8-a149-e45b3360a2502026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENCameron Pharmaceuticals2ae474dd-eaae-4401-8d42-613d672daea02026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack97d6c4ef-13b1-4b0b-a15a-f0590019940d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack852fed15-e78b-47a8-aeb4-623dfe1edad92026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENREMEDYREPACK INC.6bb65680-76ea-46e5-ae70-f3091e3603682026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
ndc (package): 70518-3486-0
ndc (package): 70518-3486-1
ndc (product): 70518-3486
ndc11 (package): 70518348601
rxcui: 198012
spl id: 4f1db6b3-e005-8431-e063-6394a90afd63
spl set id: 6bb65680-76ea-46e5-ae70-f3091e360368
unii: 57Y76R9ATQ
NaproxenNAPROXENREMEDYREPACK INC.12202ef3-c65e-45a6-88ed-5d945d8fd41c2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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