NDC 85534-0058-01 - 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: 85534-0058
Requested NDC: 85534-0058-01
Package NDCs from labels: 85534-0058-0, 85534-0058-1, 85534-0058-2, 85534-0058-3, 85534-0058-01
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
Label	Manufacturer	Effective date	Type
Naproxen - HAWAII REPACK, INC.	HAWAII REPACK, INC.	2026-06-26	HUMAN 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 11 of 11 · 204 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Cipla USA Inc.	e06c2b43-9882-442e-8413-10d9a33aecb9	2019-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 57Y76R9ATQ
NAPROXEN	NAPROXEN	TIME CAP LABORATORIES	4350a2d9-5228-460e-b7b1-27e8fa846787	2018-10-09	Warnings	Exact identifier rxcui: 198014 rxcui: 198013 rxcui: 198012 unii: 57Y76R9ATQ
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	e2347581-90da-429a-b17c-cffd0039fb86	2017-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 198014 rxcui: 198013 rxcui: 198012 unii: 57Y76R9ATQ
Naproxen	NAPROXEN	NCS HealthCare of KY, Inc dba Vangard Labs	62a12771-bde9-4bc3-9ce9-672c8e31f020	2017-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 198014 unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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