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 40 of 235 · 4,684 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
ez2go Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Valley Medical Products, LLCd64517d6-b0cc-4ba2-b260-e52faa8d4e782026-02-20WarningsExact identifier
unii: G2M7P15E5P
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC03291fd3-7b64-4b79-ad84-e1b9b30a6b032026-02-19WarningsExact identifier
unii: G2M7P15E5P
Swiftalyn Numbing CreamMENTHOL 1%GENUINE INNOVATION LTD4b2ebff2-2f50-e54b-e063-6294a90aaccb2026-02-19WarningsExact identifier
unii: L7T10EIP3A
Equate Cold Therapy Pain RelievingMENTHOLWalmart Inc46a3c9e9-5cd3-4bc4-e063-6394a90a71782026-02-19WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOLPerrigo Direct, Inc790843ce-88e2-4060-b61f-925fb30272da2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCAYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inc50776776-80aa-4098-8cf3-6daa0b305b152026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inccb4cf304-4f19-40cd-b480-9d89d19096842026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.bbf967e1-3a10-4e04-b7c5-2fcd80cc51742026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.41b8d113-59e0-41e3-b852-0ec7541cad802026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.ec4907e1-d31c-4360-97d9-dc094a5a08ac2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.2aacfe5c-36c8-4890-b6c0-a9511346761e2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLMeijer, Inc.d0cc06c1-c0d5-42f0-82cd-8b704cbe1f462026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.191f01bb-d580-4e96-89d4-ab736b75c51c2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4b1a0e6f-aa68-421c-e063-6294a90a426e2026-02-18WarningsExact identifier
unii: L7T10EIP3A
External Analgesic Cream with Menthol 5%MENTHOL 5%BLOOMWELL GARDENS LLC402faa27-5305-c73d-e063-6394a90a36f22026-02-18WarningsExact identifier
unii: L7T10EIP3A
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350American Health Packaging81374641-e54c-4b41-a3ad-49b19a0976662026-02-18WarningsExact identifier
unii: G2M7P15E5P
PAINGELMENTHOL, METHYL SALICYLATENACOR BUSINESS GROUP LLC4b1d55e2-cf83-ffbd-e063-6294a90ad52f2026-02-18WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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