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 189 of 228 · 4,553 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE066a0951-2e7e-40c0-8035-4d708a32f16c2024-06-26WarningsExact identifier
unii: 15FIX9V2JP
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact identifier
unii: L7T10EIP3A
Halls MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
unii: L7T10EIP3A
Halls StrawberryMENTHOLMondelez Global LLC75638f29-7f2a-46b0-b8a0-e87bc7d6eba12024-06-25WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1bc2f688-d0c4-690e-e063-6294a90abc382024-06-25WarningsExact identifier
unii: L7T10EIP3A
members mark omeprazoleOMEPRAZOLESam's West Inc0edfa800-fb14-44dd-9c31-de930b864ef92024-06-25WarningsExact identifier
unii: KG60484QX9
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1b9fdac0-9fb0-e669-e063-6394a90aece92024-06-24WarningsExact identifier
unii: L7T10EIP3A
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE66a91768-6012-485a-b569-a293ea6d48802024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc43539766-2e70-4b42-b64b-1d30367b2eb92024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
unii: 15FIX9V2JP
Halls StrawberryMENTHOLMondelez Global LLCde401eb4-3282-4298-8a51-15d2682534642024-06-21WarningsExact identifier
unii: L7T10EIP3A
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
unii: L7T10EIP3A
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEAurobindo Pharma Limited934601b6-fbba-43c4-a8ef-7a7dfe9f9a512024-06-17Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC76b941f0-a02f-43e8-821e-09ccf675d9442024-06-17WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.8991d464-7abc-4350-e053-2995a90a4ea72024-06-14Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OMEPRAZOLEOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3e99b78b-7fb8-4514-a3db-58e59cd429d82024-06-13Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEBoswell Pharmacy Services LLC d/b/a BPS Wholesale1ab3d84c-c563-6f04-e063-6394a90a34ff2024-06-12Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
SMOOTH GATOR Head-Ezz AnalgesicMENTHOLSmooth Gator LLC02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd2024-06-10WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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