FDA.reportPublic FDA data

NDC 70000-0175-01 - Leader 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
70000-0175
Requested NDC
70000-0175-01
Package NDCs from labels
70000-0175-1, 70000-0175-2, 70000-0175-3, 70000-0175-5, 70000-0175-4, 70000-0175-7, 70000-0175-6, 70000-0175-8, 70000-0175-9, 70000-0175-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Ibuprofen - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2026-02-25HUMAN OTC DRUG LABEL
Cardinal Health Ibuprofen Drug FactsRPK Pharmaceuticals, Inc.2022-03-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0175-1Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-1Leader Ibuprofen24 in 1 BOTTLETABLET, FILM COATED2414
70000-0175-2Leader Ibuprofen50 in 1 BOTTLETABLET, FILM COATED5014
70000-0175-2Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-3Leader Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
70000-0175-3Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-4Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
70000-0175-4Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-5Leader Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50014
70000-0175-6Leader Ibuprofen2 in 1 POUCHTABLET, FILM COATED214
70000-0175-7Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-7Leader Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12014
70000-0175-8Leader Ibuprofen200 in 1 BOTTLETABLET, FILM COATED20014
70000-0175-8Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-9Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
70000-0175-9Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0175LEADER IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]12Current NDC, Legacy NDC, 16 package rows20240131_d673266c-3d2b-479f-9b53-cdd1b8651393.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0175-1EA - Each70000-017569331b86-344b-43ea-9142-f19e3f2aa51f12018-05-09
70000-0175-2EA - Each70000-01753ba5d489-6fe5-403a-ad1e-cc378451532a12019-05-02
70000-0175-3EA - Each70000-01752d323018-e0fc-4664-acf2-a496613a8e8e12017-12-14
70000-0175-4EA - Each70000-017564aacbd6-54c7-46f4-b8c0-3160722ad7d512017-12-14
70000-0175-5EA - Each70000-0175c2b24f47-61b9-4519-9d4c-fcfab1369cf012017-12-14
70000-0175-7EA - Each70000-0175d8cec946-a77d-4c4d-91f1-d2a395641fc012018-03-08
70000-0175-8EA - Each70000-0175883670c7-42c4-4862-bc1c-53ce4757609d12022-02-07

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 103 of 189 · 3,771 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: ETJ7Z6XBU4
Motrin PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKenvue Brands LLC55403f19-58ae-450b-8a7b-0bc544088f202025-07-11WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENKroger Company91da5b64-db7f-4954-89e8-977b31247f9c2025-07-11WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENRite Aid Corporation70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d2025-07-11WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC397f1f23-10c2-569e-e063-6394a90a71642025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENSafeway0fe94b11-f7c9-4e32-976f-e5f11d01bd642025-07-09WarningsExact identifier
unii: WK2XYI10QM
Foster and Thrive IbuprofenIBUPROFENStrategic Sourcing Services LLCcf330b44-2d69-4f9f-99eb-2caa80aca8732025-07-08WarningsExact identifier
unii: WK2XYI10QM
Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltd39620db9-5099-47f0-93ad-c00e6625c4622025-07-07WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.6cf3328b-da8f-4f6b-8237-16a4d6b9c8332025-07-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.f4dad3d6-1366-4bdf-99eb-370ab74a6b9e2025-07-07WarningsExact identifier
unii: WK2XYI10QM
dg health dual back pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Incb52cfead-1cff-4e11-9953-f470fb785c732025-07-07WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAurobindo Pharma Limited21688404-41fb-487e-8ba0-aea4431a42fa2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
unii: 15FIX9V2JP
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAurohealth LLCb39fb93f-c140-40ab-8247-9559ef6df50a2025-07-03WarningsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENDr. Reddy's Laboratories Limited24731405-219c-79b4-ecf0-7d5fbfda94ba2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofen 200IBUPROFENWalgreen Company49a3d51d-55d1-4b80-ab7b-35c27a937cb92025-07-02WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Topcare ibuprofenIBUPROFENTopco Associates LLC479a0c97-dbd9-47ad-9910-9dd4edf5136f2025-07-02WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacye241ca5f-04bd-4bc9-bd0c-ca22841c4a3c2025-07-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI37eaa3b1-98e9-4fcf-ae74-153bfc35551f2025-07-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI7b2f7a68-8f5e-a340-e053-2991aa0a5aeb2025-07-01WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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