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 229 of 232 · 4,621 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS1124ba7d-a328-409b-8c88-e74bb3e501f52019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9c407dc7-fcde-4660-9a06-57bd8a6b867d2019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ChestnutOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASf07e8bb2-30ae-4337-ad60-84f55f2ff3542019-10-08WarningsExact identifier
unii: 15FIX9V2JP
Fire OutBENZOCAINE AND MENTHOLRandob Ltd.77ab634e-13d4-4f5f-87c8-73976e65a8422019-04-12WarningsExact identifier
unii: L7T10EIP3A
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCa0dc4ffa-db18-4871-9d36-51d02e3b2bd92019-03-20Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.c7cdbf2f-4841-4a7a-9056-6a741abc31332019-01-19WarningsExact identifier
unii: L7T10EIP3A
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.b8f0c61e-83b0-4835-b950-2c5dcce5cf172019-01-19WarningsExact identifier
unii: L7T10EIP3A
MEDICATED LIP BALMMENTHOL AND EUCALYPTUSBurt's Bees, Inc.30da3cc5-6140-2dee-e054-00144ff8d46c2018-12-21WarningsExact identifier
unii: L7T10EIP3A
Instaflex Pain Relief CreamMENTHOLAdaptive Health, LLC911f5021-a851-444e-8c2a-2be4fa94e8282018-12-21WarningsExact identifier
unii: L7T10EIP3A
CLE CCC Golden Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b7a4847f-b84d-4f36-8787-104eccd838a02018-12-03WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.229c20a3-6288-4ac3-9098-6d1622e906ab2018-11-29WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.fc90fb8a-44b3-47cd-882e-94ed324ed3892018-11-27WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b585f216-4234-47c5-9a6b-8b133ef48aae2018-11-27WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.14891e26-b3b6-4545-99b1-da914b7f56292018-11-24WarningsExact identifier
unii: 15FIX9V2JP
Fast FreezeCAMPHOR (NATURAL), MENTHOLNatural Essentials Inc.60c94da8-6c00-4544-a9a6-a3e87ebabd682018-10-18WarningsExact identifier
unii: L7T10EIP3A
AnalgesicMENTHOLSafetec of America, Inc.a90266d4-1e71-4805-aeca-6f8ed45135bb2018-10-01WarningsExact identifier
unii: L7T10EIP3A
COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEFMENTHOLNATURAL ESSENTIALS, INC.9fcc79e6-8176-4ebc-8602-0649b02fab862018-09-27WarningsExact identifier
unii: L7T10EIP3A
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 15FIX9V2JP
Pure-AidCAMPHOR, MENTHOL, METHYL SALICYLATEKareway Product, Inc.6def9da7-e118-fd5c-e053-2991aa0a65d22018-06-05WarningsExact identifier
unii: L7T10EIP3A
SoundbodyLIDOCAINE, MENTHOLKareway Product, Inc.6c83ec36-3e3d-07a9-e053-2a91aa0ac54c2018-05-18WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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