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 53 of 193 · 3,844 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OI LIN SUNMILK SUNSCREEN SPF 30SUNSCREEN, TITANIUM DIOXIDESunrider Manufacturing L.P.26b57314-1616-4ca4-b65f-a363c525b4322025-12-29WarningsExact identifier
unii: 15FIX9V2JP
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Childrens Ibuprofen Oral Suspension Original Berry FlavorIBUPROFENPuro Pharma Inc.6b993b25-9c81-4d75-b332-6de3f6c3b4c92025-12-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.a8b46ae5-67bc-494d-850e-b4e4ed5a33b32025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCf2a08223-a73a-5461-e053-2995a90a3bce2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCab074ae8-5696-5327-e053-2a95a90a7ce32025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENAptaPharma Inc.40936019-74ab-4b25-a502-7bbc6e12034a2025-12-26WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen GrapeIBUPROFENAptaPharma Inc.7caca7e2-6652-45fc-9538-275b43a1594e2025-12-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46a9424c-fd7d-f88b-e063-6294a90abceb2025-12-24WarningsExact identifier
unii: WK2XYI10QM
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Inc29190ebf-bb9c-4406-be7b-4427741aeb742025-12-23WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS10424ad8-74fc-4f5f-e063-6394a90a13bd2025-12-23WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
good sense ibuprofen childrensIBUPROFENPreferred Pharmaceuticals Inc.7ac61180-d668-4eec-b04f-d14f7b552a4d2025-12-23WarningsExact identifier
unii: WK2XYI10QM
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAurolife Pharma, LLC470df63a-5c0f-42df-9023-a330a901153e2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Motrin IB MigraineIBUPROFENKenvue Brands LLC34818110-5291-4bda-9571-bd77d90bba7c2025-12-22WarningsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENKenvue Brands LLCd9fc716a-fba5-45f8-8024-52325799d1dd2025-12-22WarningsExact identifier
unii: WK2XYI10QM
TINTED FACIAL SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1259035e-9196-97de-e063-6394a90a9dec2025-12-22WarningsExact identifier
unii: 15FIX9V2JP
SPF 50 MINERAL SUNSCREEN LIPZINC OXIDE , TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1c6f0964-9bee-1c06-e063-6294a90ac2a42025-12-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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