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 191 of 228 · 4,553 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Menthol Roll-OnMENTHOLVeridian Healthcare102d57a5-6449-f825-e063-6294a90a88442024-05-21WarningsExact identifier
unii: L7T10EIP3A
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
unii: 15FIX9V2JP
careone clearlaxPOLYETHYLENE GLYCOL 3350Retail Business Services, LLC2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2024-05-19WarningsExact identifier
unii: G2M7P15E5P
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
unii: 15FIX9V2JP
HealthWise Menthol 4% Roll-OnMENTHOLVeridian Healthcare1894ef00-ba05-0e02-e063-6394a90ab9822024-05-16WarningsExact identifier
unii: L7T10EIP3A
Menthol Cough DropsMENTHOLTarget Corporation Inc.187622dc-ecde-181d-e063-6294a90a4e8f2024-05-14WarningsExact identifier
unii: L7T10EIP3A
Lemon Mint DropsMENTHOLTarget Corporation Inc.1876df19-398a-23d8-e063-6394a90ae7e82024-05-14WarningsExact identifier
unii: L7T10EIP3A
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
unii: L7T10EIP3A
LIDOTHOLLIDOCAINE AND MENTHOLAdvanced Rx Pharmacy of Tennessee, LLC181f0806-dab7-410c-e063-6294a90ac09c2024-05-10Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
unii: 15FIX9V2JP
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
unii: L7T10EIP3A
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
unii: L7T10EIP3A
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-TubeMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bec1d4-2e18-4519-e053-2a95a90a1bbb2024-04-29WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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