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 21 of 236 · 4,718 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
unii: L7T10EIP3A
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
unii: L7T10EIP3A
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
unii: L7T10EIP3A
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
unii: L7T10EIP3A
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
unii: L7T10EIP3A
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
unii: L7T10EIP3A
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
unii: G2M7P15E5P
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEQPharma Incf6f6ad19-ff6a-7cd3-e053-6294a90ae1bf2026-05-11Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Cool and HeatMENTHOLAMERISOURCE BERGENf2bb0e8e-c4cd-0e8c-e053-2995a90a6df72026-05-11WarningsExact identifier
unii: L7T10EIP3A
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Instaflex Extra Strength Pain Relief CreamMENTHOL, METHYL SALICYLATEHealthy Directions, LLCd058c64d-0e4f-45aa-8f52-804961b562e32026-05-11WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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