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 8 of 236 · 4,718 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wini By Locsanity Advanced Formula Muscle Joint Relief BalmMETHYL SALICYLATE,CAMPHOR,MENTHOLLocsanity LLC5829b5d7-78d4-78a2-e063-6394a90a3dfc2026-08-03WarningsExact identifier
unii: L7T10EIP3A
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEProficient Rx LP062800b1-790a-41c3-a8be-94143d2c7fb62026-08-01Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
unii: L7T10EIP3A
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.96104ea6-c08f-40b5-83f5-d840b317f1fd2026-07-31Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
unii: L7T10EIP3A
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
unii: L7T10EIP3A
Rugby Muscle Rub CreamMUSCLE RUB CREAMPreferred Pharmaceuticals Inc.ea209a4e-acad-413b-8fb9-27e98130bcd62026-07-28WarningsExact identifier
unii: L7T10EIP3A
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
unii: L7T10EIP3A
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
unii: L7T10EIP3A
HEMPE Ice Muscle and Joint GelMENTHOLHealthcare International Research Limited57aec922-1de4-c579-e063-6394a90af6c82026-07-28WarningsExact identifier
unii: L7T10EIP3A
Green bud SOOTHING MASSAGE FLUIDGREEN BUD SOOTHING MASSAGE FLUIDWANWANG INC57b01b7b-0ea9-f8c9-e063-6394a90a95c62026-07-28WarningsExact identifier
unii: L7T10EIP3A
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
unii: L7T10EIP3A
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
unii: L7T10EIP3A
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
unii: L7T10EIP3A
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
unii: L7T10EIP3A
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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