FDA.reportPublic FDA data

NDC 59368-308 - omeprazole

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
59368-308
Package NDCs from labels
59368-308-02, 59368-308-01
Manufacturer
Sixarp, LLC
Effective date
2025-09-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
omeprazole - Sixarp, LLCSixarp, LLC2025-09-19HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-308OMEPRAZOLE TABLET, DELAYED RELEASE [PRAXIS, LLC]1Unmatched20250309_2fc3704c-daac-3e18-e063-6394a90a47ea.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 142 of 232 · 4,621 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone omeprazoleOMEPRAZOLERetail Business Services, LLC063cfad8-3ca6-4b72-a4c9-512b8047bae32025-04-17WarningsExact identifier
unii: KG60484QX9
leader omeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leader19beab17-ca25-4be3-bada-20a2e9aa26b52025-04-16WarningsExact identifier
unii: KG60484QX9
rugby omeprazoleOMEPRAZOLERugby Laboratories61952807-f38d-4e7a-8646-a8ec85d7fb372025-04-15WarningsExact identifier
unii: KG60484QX9
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-PatchMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd32b7d73c-a191-7843-e063-6394a90aa6312025-04-14WarningsExact identifier
unii: L7T10EIP3A
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
unii: 15FIX9V2JP
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCe13ab4d3-eb58-4874-925a-6a59df4dd29a2025-04-14WarningsExact identifier
unii: L7T10EIP3A
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
unii: 15FIX9V2JP
careone omeprazoleOMEPRAZOLEAmerican Sales Companya5ec923a-dbc7-43e0-b3b8-f61dcaa6765d2025-04-14WarningsExact identifier
unii: KG60484QX9
signature care omeprazoleOMEPRAZOLESafeway85ece978-3cfb-4c09-bf0f-3217fda8e7d42025-04-14WarningsExact identifier
unii: KG60484QX9
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC71a36691-9d9e-479d-bfdc-6f6b192ad2d02025-04-11WarningsExact identifier
unii: L7T10EIP3A
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee467ec4-bd5e-644a-e053-2a95a90ac2732025-04-10WarningsExact identifier
unii: L7T10EIP3A
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedda3358ae-8679-6045-e053-2a95a90a50e32025-04-10WarningsExact identifier
unii: L7T10EIP3A
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
unii: 15FIX9V2JP
WincoPOLYETHYLENE GLYCOL 3350WINCO FOODSd649f758-a46f-4864-8718-878ee5a74bfc2025-04-10WarningsExact identifier
unii: G2M7P15E5P
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
unii: 15FIX9V2JP
Zepol Topical AnalgesicCAMPHOR, MENTHOLLaboratorios Zepol S.A.ca20ade6-9b35-40bb-b3b2-fc3a0e1eece92025-04-09WarningsExact identifier
unii: L7T10EIP3A
MUSCLEMENTHOLWATER-JEL TECHNOLOGIES1af399af-07b0-4899-9bcc-1e244b63b1cf2025-04-08WarningsExact identifier
unii: L7T10EIP3A
Lidocaine with MentholLIDOCAINE HCL AND MENTHOLKareway Product, Inc.9ee46a5b-d00c-4254-e053-2995a90aeb3a2025-04-08WarningsExact identifier
unii: L7T10EIP3A
OARS AND ALPS MUSCLE RECOVERY BALMMENTHOL, METHYL SALICYLATECosco International, Inc8745802f-018d-4cf8-bbf3-3b04c8f545382025-04-08WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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