NDC 70518-3822-01 - 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
70518-3822
Requested NDC
70518-3822-01
Package NDCs from labels
70518-3822-0, 70518-3822-1, 70518-3822-2, 70518-3822-3, 70518-3822-4, 70518-3822-5, 70518-3822-6, 70518-3822-7, 70518-3822-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-08
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.2026-06-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3822-0Naproxen30 in 1 BLISTER PACKTABLET308
70518-3822-1Naproxen60 in 1 BOTTLE, PLASTICTABLET608
70518-3822-2Naproxen20 in 1 BOTTLE, PLASTICTABLET208
70518-3822-3Naproxen30 in 1 BOTTLE, PLASTICTABLET308
70518-3822-4Naproxen14 in 1 BOTTLE, PLASTICTABLET148
70518-3822-5Naproxen6 in 1 BLISTER PACKTABLET68
70518-3822-6Naproxen28 in 1 BOTTLE, PLASTICTABLET288
70518-3822-7Naproxen12 in 1 BOTTLE, PLASTICTABLET128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3822NAPROXEN TABLET [REMEDYREPACK INC.]7Current NDC, 8 package rows20241204_ccd95dfc-9236-4707-a715-6a12c91519ff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3822-1EA - Each70518-38220b97331a-046f-43a9-bf82-107d3c25e09c12026-01-08

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 10 of 11 · 204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENA-S Medication Solutionsa8b54258-84e7-41e8-9e51-137a3f442e6b2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba42023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions50c52976-9e04-4a5e-9f21-aca3ea5c29242023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsd801ba16-e2ec-4bb2-8cff-32388634b35a2023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions21930f73-d3c2-4462-a487-74ed871b74b22023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutionsa5ea3a84-7acd-4f24-9f0f-9f871ce1b5f42023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
naproxenNAPROXENCipla USA Inc.a9549a47-3fa4-4a2b-95ac-b00e43aedae72023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPd0670241-f1f9-4fdf-83d4-547e7b8008112022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENAsclemed USA, Inc.a4fcb411-c918-459b-adc6-06dfa8ed8a502022-10-12WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPaa4d159c-9cbe-4d29-9532-33a312f1ae052022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198013
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LP96601d76-50ea-4dc0-b588-d174f8d8bb512022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC98efdeb8-ea38-456e-953f-ba589727f2842021-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC9c963e77-6e05-47d0-a8d3-e581777377b92021-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NAPROXENNAPROXENAphena Pharma Solutions - Tennessee, LLC32693390-763b-46dd-b821-65a7bf3c66712021-04-26WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LPfc3ee94a-adb7-411e-a662-2f2c6ddbabaf2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LP3e4e5371-d796-47c7-95c1-d99e82a0b2822021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC3e14f839-d1e4-44df-a457-29f005b3e62e2020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NAPROXENNAPROXENBryant Ranch Prepack5d399bf3-db49-411a-91b9-b410d702a65a2020-12-14WarningsExact identifier
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENExelan Pharmaceuticals, Inc.46dbdb95-a0d0-4410-8d64-b22763b12af72020-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
NaproxenNAPROXENProficient Rx LP69a3afd6-d64b-4f07-b848-b0d3fc19f2a22019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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