FDA.reportPublic FDA data

NDC 70518-4439-01 - 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
70518-4439
Requested NDC
70518-4439-01
Package NDCs from labels
70518-4439-0, 70518-4439-1, 70518-4439-2, 70518-4439-3, 70518-4439-4, 70518-4439-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-09
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.2026-04-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4439-0Naproxen12 in 1 BOTTLE, PLASTICTABLET125
70518-4439-1Naproxen20 in 1 BOTTLE, PLASTICTABLET205
70518-4439-2Naproxen30 in 1 BOTTLE, PLASTICTABLET305
70518-4439-3Naproxen90 in 1 BOTTLE, PLASTICTABLET905
70518-4439-4Naproxen30 in 1 BOTTLE, PLASTICTABLET305

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 7 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Oral SuspensionNAPROXEN ORALANI Pharmaceuticals, Inc.252726a7-757a-4b97-b5b8-ffff4ac1d1032025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENBryant Ranch Prepack9d7bc470-fbba-40a6-a56c-f681a3cee9cf2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.727913f6-9542-4a2d-9318-4b7ff521bffd2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENAmneal Pharmaceuticals of New York LLC2718e0b7-1ce6-457e-bee9-11b634dfd3532025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENANI Pharmaceuticals, Inc.052e6fe3-d619-42c3-b64e-67c7aaf7271c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMScieGen Pharmaceuticals, Inc167340c2-1234-4d00-b4e2-cccf3d270fda2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack3f1c66f0-2d9d-4be1-8656-1dbed2c9c7152025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENDirect_Rxf499a207-02c8-a338-e053-2995a90accc02025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepackf3a3eea2-f6b3-4559-8536-26c1125df3e12025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NAPROXENNAPROXENDIRECT RXb1b78c49-82e9-2402-e053-2a95a90ae35f2025-01-17WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack19aadd4b-647b-4c75-9059-9a2c68a185612025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ad850-57b5-a21d-e053-2a95a90ae68e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a94a8-3825-eabd-e053-2a95a90acd582024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a96cf-1cda-8ace-e053-2a95a90a18cc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ac948-4405-5abf-e053-2995a90af2b52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9aa7a0-e287-5935-e053-2995a90a1d112024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLCd292f376-1844-b01c-e053-2a95a90a09272024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAsclemed USA, Inc.7b3af5a8-0c92-43f4-af13-7a47dca20e922024-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited1ef3fe94-9bbb-934d-a09b-d19a1d23a4d52024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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