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 37 of 193 · 3,844 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
application number: ANDA072096
rxcui: 310965
unii: WK2XYI10QM
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.70e191ef-8fad-49eb-9850-fceea119e92f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.b84ea215-e61d-4c00-8a34-d47c4080779b2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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