FDA.reportPublic FDA data

NDC 59368-321 - 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
59368-321
Package NDCs from labels
59368-321-02, 59368-321-01, 59368-321-03
Manufacturer
Sixarp, LLC
Effective date
2025-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
omeprazole - Sixarp, LLCSixarp, LLC2025-09-22HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-321OMEPRAZOLE TABLET, DELAYED RELEASE [PRAXIS, LLC]1Unmatched20250322_30ca370c-c38f-4ad3-e063-6294a90af87f.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 50 of 235 · 4,684 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ebcc2c6c-a039-48d5-8c1c-5b347254c4c22026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6967f8bc-3092-44a9-926a-6c11676425e52026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.37d4d8c1-e76b-48a3-9a13-f0543af1b28f2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.fa5046f2-a6db-4ac3-a78f-1b5df075d7e82026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.0c5fc63f-1899-4406-944a-1cdcdf8b42772026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.58a84ecd-3f27-40fc-8e0b-e29192679e6b2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
ULTRA RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION48ea80cf-af54-ce5f-e063-6394a90ac4932026-01-21WarningsExact identifier
unii: L7T10EIP3A
Healthy Back Institute Rub On ReliefANALGESICEagle Labs Inc.17dff3c1-3c0b-16f6-e063-6394a90a3c052026-01-21WarningsExact identifier
unii: L7T10EIP3A
Pain ReliefANALGESICFullstack Fulfillment2a433cee-8b6f-c280-e063-6394a90ae25a2026-01-21Exact identifier
unii: L7T10EIP3A
sunscreenTITANIUM DIOXIDEGuangdong Zhoubang Biotechnology Co., Ltd48f13b1c-8104-881b-e063-6394a90a816d2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
unii: 15FIX9V2JP
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2026-01-20Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
SIMPLY VITAL PAIN RELIEF HEMPMENTHOLALPHA PLANTS INCc14f4c06-cfe5-497e-9f9e-b2ba442e61bb2026-01-19WarningsExact identifier
unii: L7T10EIP3A
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
unii: L7T10EIP3A
VAPORXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLAKRON PHARMA INC51b32162-0c5a-4b5b-999a-34337d8166032026-01-19WarningsExact identifier
unii: L7T10EIP3A
AsperFlexMENTHOL AND METHYL SALICYLATEAkron Pharma Inc.117de175-976d-44f3-85ed-3d127fbe3a7c2026-01-19WarningsExact identifier
unii: L7T10EIP3A
Equate Pain Relieving Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATEWal-Mart Stores Inc5ed1d7b3-925e-4a18-8e15-636f5b442ad72026-01-19WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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