FDA.reportPublic FDA data

NDC 70000-0263-01 - LEADER CHILDRENS IBUPROFEN

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
70000-0263
Requested NDC
70000-0263-01
Package NDCs from labels
70000-0263-1, 70000-0263-2, 70000-0263-3, 70000-0263-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEADER CHILDRENS IBUPROFEN - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2025-03-03HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0263-1LEADER CHILDRENS IBUPROFEN1 in 1 CARTONSUSPENSION15
70000-0263-1LEADER CHILDRENS IBUPROFEN120 mL in 1 BOTTLESUSPENSION1205
70000-0263-2LEADER CHILDRENS IBUPROFEN240 mL in 1 BOTTLESUSPENSION2405
70000-0263-2LEADER CHILDRENS IBUPROFEN1 in 1 CARTONSUSPENSION15
70000-0263-3LEADER CHILDRENS IBUPROFEN150 mL in 1 BOTTLESUSPENSION1505
70000-0263-3LEADER CHILDRENS IBUPROFEN1 in 1 CARTONSUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0263LEADER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER]5Current NDC, Legacy NDC, 6 package rows20250305_913a4bd0-0784-45b4-b05e-3e7c016bbb86.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0263-1ML - Milliliter70000-0263fbb179f2-5d83-4b39-a4c8-7f816a8d06e212017-11-06
70000-0263-2ML - Milliliter70000-0263fbe88e6f-ef78-4794-b3b0-585c7211eea812017-11-06
70000-0263-3ML - Milliliter70000-02635146b58d-9db9-4309-b673-3ed748b15b8612018-03-08

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 9 of 86 · 1,715 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.3c1c1b65-f57f-62b0-e063-6294a90a10212026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3802982a-2373-9ca3-e063-6394a90a0ab72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.4573753d-117b-a6f2-e063-6394a90ae2f92026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3ed7faff-fd48-0a83-e063-6394a90aab142026-06-23WarningsExact identifier
unii: WK2XYI10QM
Pain ReliefIBUPROFENAlbertsons Companiesf9deaeb7-efb3-4019-e053-6394a90a33d62026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.bc15fea8-0d86-4546-e053-2995a90abee32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a13ac87b-b395-685e-e053-2a95a90ab5d32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWhole Foods Market, INC.32348505-744c-fbfd-e063-6394a90a82d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGEN1afcf0c6-bd41-4621-9e44-d97b81221c122026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGENa13cee82-1c4e-0cbe-e053-2a95a90a3ab82026-06-23WarningsExact identifier
unii: WK2XYI10QM
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTopco Associates, LLC59a88ca7-eb37-46de-9134-a5a6d330bd492026-06-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC8ea0e303-3967-4d71-8255-ac42a841ce282026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC548c705e-4094-fc6f-e063-6394a90a34262026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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