FDA.reportPublic FDA data

NDC 68210-4096-01 - NAPROXEN SODIUM

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
68210-4096
Requested NDC
68210-4096-01
Package NDCs from labels
68210-4096-1, 68210-4096-01
Manufacturer
SPIRIT PHARMACEUTICALS,LLC
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NAPROXEN SODIUM - SPIRIT PHARMACEUTICALS,LLCSPIRIT PHARMACEUTICALS,LLC2024-12-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4096-1NAPROXEN SODIUM365 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3657

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4096NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC]7Current NDC, Legacy NDC, 1 package rows20250101_a690dc39-95f2-4853-a291-05d7dc9a1551.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 3 of 117 · 2,336 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Back and Muscle PainNAPROXEN SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4039504c-e612-4503-854a-62ee067809562026-07-13WarningsExact identifier
unii: 9TN87S3A3C
naproxen sodiumNAPROXEN SODIUMH E Bb5dcf3df-2628-49c7-9d96-64886bebe6312026-07-13WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)c28c4fd2-1428-421c-b62f-265e472d833e2026-07-09WarningsExact identifier
unii: 9TN87S3A3C
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Naproxen SodiumNAPROXEN SODIUMScieGen Pharmaceuticals, Inc.79f48c92-783d-40f2-9865-89958a9f9de62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMMeijer Distribution Inc34d635f8-9703-4c29-92a5-85d3b47c4c932026-07-07WarningsExact identifier
unii: 9TN87S3A3C
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
Aleve CapletsNAPROXEN SODIUMSelect Consumer Group3ca84972-f8c9-1881-e063-6294a90a90702026-07-03WarningsExact identifier
unii: 9TN87S3A3C
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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