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 213 of 232 · 4,621 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SMOOTH GATOR 60-second Pain ReliefCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC3b74b542-202f-469e-8025-4372e95e6b012023-11-10WarningsExact identifier
unii: L7T10EIP3A
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f8b8d1-a20b-54b0-e054-00144ff88e882023-11-10WarningsExact identifier
unii: L7T10EIP3A
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f92e71-fe2e-16f4-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: L7T10EIP3A
Teeter Renew Muscles Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCb90dc5b9-c31d-4770-a291-98d036ae87232023-11-10WarningsExact identifier
unii: L7T10EIP3A
SMOOTH GATOR Foot and Leg RubCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC57094238-506b-48c1-8eb9-fe904be80df02023-11-10WarningsExact identifier
unii: L7T10EIP3A
Teeter reNEW MUSCLES Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCebc777b0-d141-4a62-9366-d14787eaefe02023-11-10WarningsExact identifier
unii: L7T10EIP3A
FEELGOOD LAB Natural Pain CreamMENTHOLThe Feel Good Lab, LLC799d464c-aaf1-429a-877b-2a692397bb492023-11-10WarningsExact identifier
unii: L7T10EIP3A
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f93076-1f68-58e6-e054-00144ff88e882023-11-10WarningsExact identifier
unii: L7T10EIP3A
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f9622e-27c7-6a5d-e054-00144ff88e882023-11-10WarningsExact identifier
unii: L7T10EIP3A
FEEL GOOD LAB Natural Pain CreamMENTHOLTHE FEEL GOOD LAB, LLC774a72b1-b719-4217-846e-7f9921fd1b162023-11-10WarningsExact identifier
unii: L7T10EIP3A
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)TITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4935f888-cd92-61d1-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a507-863f-1088-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: 15FIX9V2JP
CoralSafe Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDEElements Brandse6e00896-b7e5-41c6-a72b-08e600758cf52023-11-10WarningsExact identifier
unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a3ad-6379-108a-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: 15FIX9V2JP
Welby ClearLaxPOLYETHYLENE GLYCOL 3350Aldi, Incd64caba5-614f-4edc-bb47-ce4fed38ce452023-11-10WarningsExact identifier
unii: G2M7P15E5P
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolfb677ad0-2791-44ec-9720-951471ec009a2023-11-09WarningsExact identifier
unii: 15FIX9V2JP
Shaklee Youth Age Defense Mineral Moisturizer SPF 30TITANIUM DIOXIDEShaklee Corporationf4888fdc-09f9-43de-8c81-5a0f5e767d4e2023-11-09WarningsExact identifier
unii: 15FIX9V2JP
Spit and Polish Sun Smart SunscreenTITANIUM DIOXIDE, ZINC OXIDENaturally Uncommon, LLCaf879a05-1483-5c11-e053-2995a90af45d2023-11-09WarningsExact identifier
unii: 15FIX9V2JP
Valtrum Aerobic SportsSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC33f2491e-c1f2-4e5a-acbe-8ace844b88d62023-11-09WarningsExact identifier
unii: L7T10EIP3A
EltaMD UV ActiveZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd22023-11-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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