FDA.reportPublic FDA data

NDC 67046-1553-03 - 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
67046-1553
Requested NDC
67046-1553-03
Package NDCs from labels
67046-1553-3, 67046-1553-03
Manufacturer
Coupler LLC
Effective date
2025-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - Coupler LLCCoupler LLC2025-04-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1553-3Naproxen30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1553NAPROXEN TABLET [COUPLER LLC]1Current NDC, 1 package rows20250425_3375e139-d9de-8c2d-e063-6394a90a653d.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 1 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENCoupler LLC5954565a-d9bd-9e26-e063-6294a90a03cb2026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENREMEDYREPACK INC.88a548d1-97c0-46d0-825a-75ef689d64702026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.24d44eb6-921e-4150-a6b2-81f42ced32ab2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.49a00870-f580-4eb9-a95d-48fa956f147f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals, Inc.9f026fd5-f996-4383-b528-841d38d3dab52026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.c5e52ddd-a909-487a-bb46-01ad356906652026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.65b892f2-8385-4bb0-8121-a58b01e8d13d2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LPcfd4ef00-cfc4-4794-99fe-faa45eb2f6172026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENHAWAII REPACK, INC.888efc91-b4de-4691-b84c-fb871e7a6dfe2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENSt. Mary's Medical Park Pharmacye3a3e5d2-2d1e-74d3-e053-2995a90a82bf2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENCoupler LLC545fe39a-4777-b149-e063-6394a90a53cf2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENCoupler LLC53e6519a-cb52-85e2-e063-6394a90abdcf2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENREMEDYREPACK INC.ccd95dfc-9236-4707-a715-6a12c91519ff2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENST. MARY'S MEDICAL PARK PHARMACYe3a4ab4a-b109-eb5e-e053-2a95a90afddd2026-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
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
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
rxcui: 198013
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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