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 9 of 117 · 2,336 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEPort Jervis Laboratories, Inc51169bed-2091-ad2b-e063-6294a90a84b62026-05-05WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Naproxen SodiumNAPROXEN SODIUMAmazon.com Services LLC04a298dc-c525-8198-e063-6294a90a6f962026-04-27WarningsExact identifier
unii: 9TN87S3A3C
ALL NIGHT PAIN RELIEF PMDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMWalgreen Company43e4ed28-b1be-4548-86ac-f40f9f83f04e2026-04-27WarningsExact identifier
unii: 9TN87S3A3C
Medique MediproxenNAPROXEN SODIUMSportpharm LLCf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2026-04-24WarningsExact identifier
unii: 9TN87S3A3C
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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