FDA.reportPublic FDA data

NDC 85534-0023-01 - 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
85534-0023
Requested NDC
85534-0023-01
Package NDCs from labels
85534-0023-0, 85534-0023-1, 85534-0023-2, 85534-0023-3, 85534-0023-01
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - HAWAII REPACK, INC.HAWAII REPACK, INC.2026-06-26HUMAN PRESCRIPTION DRUG LABEL

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 6 of 11 · 204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENBryant Ranch Prepacke0f430fd-4511-41c8-b5e9-894abe4f3c372025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionscfa88511-40bb-4658-b606-44c68d0746b72025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsb500bdba-946a-41ff-855c-1f2937547d012025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAurobindo Pharma Limited570974d4-0d5b-4df2-b307-37380511835d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.2d01e583-670a-46f4-b5f2-3fad46d0376f2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack124af155-0661-4054-9800-de547d8212d72025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENZameer Pharmaceuticals LLCd2e5553a-7c90-407c-9f07-3be65560c23a2025-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC3a652450-525b-4839-e063-6294a90ac2872025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc470496f5-a71d-40b2-bf11-3a8d3d7909622025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC3a6637ca-0c55-f648-e063-6294a90aaef72025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.29d98cf3-a0f2-3f89-e054-00144ff88e882025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.6573681e-e9be-440f-a818-a533b744648e2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPe64b3b36-f96e-463e-aca8-8f6e86724bcf2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENAurobindo Pharma Limited0e5315bc-c02f-4749-be69-b5b528327d582025-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAmneal Pharmaceuticals LLCc43a43e2-e867-448d-8f59-3efc7c077cbc2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions7fef9311-471b-472c-b4f2-c952a2b3a2552025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENCamber Pharmaceuticals, Inc.fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd2025-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENCoupler LLC3375e139-d9de-8c2d-e063-6394a90a653d2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionse63a034d-23ef-458f-88ed-8b6d736996212025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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