FDA.reportPublic FDA data

NDC 41520-802-01 - careone 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
41520-802
Requested NDC
41520-802-01
Package NDCs from labels
41520-802-01, 41520-802-03
Manufacturer
American Sales Company
Effective date
2025-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
careone omeprazole - American Sales CompanyAmerican Sales Company2025-04-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-802-01careone omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
41520-802-03careone omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-802CAREONE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [AMERICAN SALES COMPANY]3Current NDC, Legacy NDC, 2 package rows20250418_a5ec923a-dbc7-43e0-b3b8-f61dcaa6765d.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 105 of 234 · 4,674 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
unii: L7T10EIP3A
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
unii: L7T10EIP3A
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
unii: L7T10EIP3A
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
unii: L7T10EIP3A
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsExact identifier
unii: G2M7P15E5P
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
unii: L7T10EIP3A
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
unii: KG60484QX9
Gold Bond Medicated Extra Strength BodyMENTHOLGold Bond Co LLC7b75b7de-9c0b-4edf-b923-320f7d2bb1e62025-12-04WarningsExact identifier
unii: L7T10EIP3A
LidoPatch Pain ReliefLIDOCAINE, MENTHOLJAR Laboratories07289aa1-43ed-df31-e063-6394a90a764a2025-12-03WarningsExact identifier
unii: L7T10EIP3A
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dd5d63-1376-1ff7-e053-2a95a90a1d942025-12-03Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Health One Deep Relieving GelDEEP RELIEVING GELONE2ZEE LIMITED LIABILITY COMPANY41d837f1-09e4-4ce3-8c1a-725c2147c7de2025-12-03WarningsExact identifier
unii: L7T10EIP3A
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
unii: L7T10EIP3A
OmeprazoleOMEPRAZOLERedpharm Drug44f59d88-d401-950b-e063-6294a90a2a502025-12-02WarningsExact identifier
rxcui: 402014
unii: KG60484QX9
5Kind DMSOMENTHOL, METHYL SALICYLATE5KIND TRADING LTD6a6c7241-f544-4784-9581-f5b172fdbec72025-12-02WarningsExact identifier
unii: L7T10EIP3A
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
SUNSET COOLING PAIN RELIEF ROLL-ONMENTHOLSUNSET NOVELTIES, INC45037bc1-aa03-11ae-e063-6294a90a6c962025-12-02WarningsExact identifier
unii: L7T10EIP3A
OmeprazoleOMEPRAZOLEA-S Medication Solutions17ccdbe0-19c1-498d-8e81-578be549b4e52025-12-02Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
WalgreensPOLYETHYLENE GLYCOL 3350WALGREEN COMPANY97489a02-db59-4529-a091-abc737e44a962025-12-01WarningsExact identifier
unii: G2M7P15E5P
CareAll Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUSNew World Imports, Inc4cd2f751-e072-4f4e-b059-ed1dfcc60c6b2025-12-01WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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