FDA.reportPublic FDA data

NDC 59368-321-01 - 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
59368-321
Requested NDC
59368-321-01
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 135 of 232 · 4,621 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
unii: L7T10EIP3A
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
unii: L7T10EIP3A
HALLS Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
unii: L7T10EIP3A
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
unii: 15FIX9V2JP
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
unii: L7T10EIP3A
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
unii: L7T10EIP3A
24/7 Life Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENTLil' Drug Store Products, Inc.f03430d4-8dbb-4fc0-e053-2a95a90a119d2025-07-02WarningsExact identifier
unii: L7T10EIP3A
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
unii: L7T10EIP3A
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
unii: L7T10EIP3A
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact identifier
unii: 15FIX9V2JP
Bonica EaseX Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.34f1196a-fda1-4bef-be71-e5a09ee97bc12025-06-27WarningsExact identifier
unii: L7T10EIP3A
MedlineMENTHOLMedline Industries, LP0d947aa6-045e-d001-e063-6294a90a36572025-06-26WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cough DropsMENTHOLCVS Pharmacyf038b713-0721-2bb5-e053-2a95a90a78422025-06-26WarningsExact identifier
unii: L7T10EIP3A
PHIZICO Pain ReliefMENTHOLER3 BRANDS INC.72715dc5-d1e7-4b4b-8e28-4e367abba3222025-06-25WarningsExact identifier
unii: L7T10EIP3A
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
Diva Cramp Care CreamMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp37368566-b14e-4d5c-bdde-6eea9073974f2025-06-25WarningsExact identifier
unii: L7T10EIP3A
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
unii: 15FIX9V2JP
Aroamas Cot Nicotine Transdermal Patches KitNICOTINE TRANSDERMAL PATCHESPCHEERY LLC38576022-9413-c9af-e063-6294a90afd462025-06-24WarningsExact identifier
unii: L7T10EIP3A
NERVE REVERSE PAIN RELIEFMENTHOLPogue Medical Servicesda97bcc6-5aa8-48e2-a2c2-c937745bf6d32025-06-23WarningsExact identifier
unii: L7T10EIP3A
Medterra Pain Relief Menthol Roll-OnMENTHOLRespect Manufacturing Corporation05a6067a-287a-52d4-e063-6394a90a2c4e2025-06-23WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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