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 188 of 232 · 4,640 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Careland Plantar Fasciitis Hydrogel Pain PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.0e2f29c2-2e95-4be0-b7e9-f1761a1321a52024-08-21WarningsExact identifier
unii: L7T10EIP3A
Real Time Pain Relief Maxx Topical AnalgesicMENTHOLREAL TIME PRODUCTS, INCf45eb95a-2813-4124-bdb0-54e078a8237d2024-08-20WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited09243a23-1f17-f77b-e063-6394a90a0b222024-08-19WarningsExact identifier
unii: L7T10EIP3A
NuviraCAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%Strand Health Groupff448183-03cf-df2d-e053-6394a90a77f02024-08-16WarningsExact identifier
unii: L7T10EIP3A
MACKENZIES OCEAN SAFE SUNSCREENTITANIUM DIOXIDENaturally Uncommon, LLC1fd0a790-c66c-216f-e063-6294a90ae9712024-08-16WarningsExact identifier
unii: 15FIX9V2JP
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC54e0d57e-1f48-45e2-86b3-0e50775996f42024-08-15WarningsExact identifier
unii: L7T10EIP3A
FLANAXMETHYL SALICYLATE, MENTHOL, CAPSAICINBelmora LLC5e06c688-a086-4c1c-8dab-fcead61fef402024-08-13WarningsExact identifier
unii: L7T10EIP3A
OmeprazoleOMEPRAZOLELiving Better Brands LLC1d500e2d-395b-437e-a95c-3922a71a09562024-08-12WarningsExact identifier
unii: KG60484QX9
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Pain ReliefMENTHOLPain Relieving Spray Inc.1f44466f-044f-70fe-e063-6294a90ad5752024-08-09WarningsExact identifier
unii: L7T10EIP3A
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
unii: 15FIX9V2JP
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC73c36634-a70f-4641-910f-6cdda7fbcd362024-08-08WarningsExact identifier
unii: KG60484QX9
Meijer Cold Therapy Pain RelievingMENTHOLMeijer Inc1c5b55e3-f859-71b6-e063-6294a90a633b2024-08-08WarningsExact identifier
unii: L7T10EIP3A
HealthWise Soothing Cold Therapy GelMENTHOL 4%Veridian Healthcare1f09ccdd-09d8-6a8d-e063-6394a90a184f2024-08-08WarningsExact identifier
unii: L7T10EIP3A
OmeprazoleOMEPRAZOLEA-S Medication Solutionsfe7d3352-d53f-4046-92ed-1eb5c917fbee2024-08-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions8d925ca6-83f1-4263-8218-4bf7cc8ceb392024-08-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack2b7491dd-19f5-42e0-b901-7ba71a3820c72024-08-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack17664f71-154a-47c6-b83c-b349bbc8a98f2024-08-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions9378c870-f2cc-4a60-b0fd-08a4d43857bc2024-08-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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