FDA.reportPublic FDA data

NDC 59640-047-01 - 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
59640-047
Requested NDC
59640-047-01
Package NDCs from labels
59640-047-01, 59640-047-03
Manufacturer
H E B
Effective date
2025-02-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
omeprazole - H E BH E B2025-02-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59640-047-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
59640-047-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59640-047OMEPRAZOLE TABLET, DELAYED RELEASE [H E B]3Current NDC, Legacy NDC, 2 package rows20250304_501d80c0-68ee-4fd9-bc56-0b214dbf72b5.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 186 of 224 · 4,464 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acid ReducerOMEPRAZOLEFamily Dollar Stores, LLC6d8daf78-1672-4bbf-a022-514bf0a5ac9a2024-06-17WarningsExact identifier
rxcui: 402014
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC76b941f0-a02f-43e8-821e-09ccf675d9442024-06-17WarningsExact identifier
application number: NDA022032
rxcui: 402014
unii: KG60484QX9
Acid ReducerOMEPRAZOLENORTHEAST PHARMA35ceccb5-dc3d-4ee1-bdac-35cb52c22f592024-06-15WarningsExact identifier
rxcui: 402014
Acid ReducerOMEPRAZOLECardinal Health230e1aca-6644-4e6d-a6e1-9ba04cdcc8a82024-06-15WarningsExact identifier
rxcui: 402014
Acid ReducerOMEPRAZOLEBi-Mart419659f9-098a-4a18-8bba-cd45157bfa502024-06-15WarningsExact identifier
rxcui: 402014
Acid ReducerOMEPRAZOLEWALGREEN CO.b9561780-e358-b610-e053-2a95a90af0202024-06-15WarningsExact identifier
rxcui: 402014
Acid ReducerOMEPRAZOLEKROGER COMPANYeb5d02a8-4112-2066-e053-2a95a90abba32024-06-15WarningsExact identifier
rxcui: 402014
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.8991d464-7abc-4350-e053-2995a90a4ea72024-06-14Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Acid ReducerOMEPRAZOLEAurohealth LLCfde12bf8-3e3b-4813-a8c4-4385e7de82042024-06-14WarningsExact identifier
rxcui: 402014
Acid ReducerOMEPRAZOLEWal-Mart Stores, Inc.1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c2024-06-14WarningsExact identifier
rxcui: 402014
Acid ReducerOMEPRAZOLEWinco Foods, LLC.0cb2949a-baf2-4276-a27b-8f3cc4b9a6582024-06-14WarningsExact identifier
rxcui: 402014
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
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
unii: 15FIX9V2JP
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMNuCare Pharmaceuticals,Inc.66ff9726-20da-688a-e053-2a91aa0a59ac2024-06-06WarningsExact identifier
unii: L7T10EIP3A
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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