NDC 70518-3822-03 - 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
70518-3822
Requested NDC
70518-3822-03
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, 70518-3822-03
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 1 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.24d44eb6-921e-4150-a6b2-81f42ced32ab2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals Inc.49a00870-f580-4eb9-a95d-48fa956f147f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPreferred Pharmaceuticals, Inc.9f026fd5-f996-4383-b528-841d38d3dab52026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
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
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LPcfd4ef00-cfc4-4794-99fe-faa45eb2f6172026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENUnit Dose Solutions, Inc.55652203-e5f3-78dc-e063-6294a90a3e462026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENHAWAII REPACK, INC.888efc91-b4de-4691-b84c-fb871e7a6dfe2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
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
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
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
application number: ANDA212517
ndc (package): 70518-3822-5
ndc (package): 70518-3822-4
ndc (package): 70518-3822-0
ndc (package): 70518-3822-1
ndc (package): 70518-3822-7
ndc (package): 70518-3822-3
ndc (package): 70518-3822-6
ndc (package): 70518-3822-2
ndc (product): 70518-3822
ndc11 (package): 70518382203
rxcui: 198014
spl id: 53c283c3-2de7-cd02-e063-6394a90ab181
spl set id: ccd95dfc-9236-4707-a715-6a12c91519ff
unii: 57Y76R9ATQ
NaproxenNAPROXENST. MARY'S MEDICAL PARK PHARMACYe3a4ab4a-b109-eb5e-e053-2a95a90afddd2026-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198012
unii: 57Y76R9ATQ
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-06-03WarningsExact identifier
unii: FZ989GH94E
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