FDA.reportPublic FDA data

NDC 59368-003 - up and up dye free infants concentrated 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
59368-003
Package NDCs from labels
59368-003-01, 59368-003-02
Manufacturer
Sixarp, LLC
Effective date
2024-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
up and up dye free infants concentrated ibuprofen - Sixarp, LLCSixarp, LLC2024-03-15HUMAN OTC DRUG LABEL

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 84 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENRITE AID CORPORATIONa7aa790a-6d6c-7929-e053-2995a90a1cf82022-01-04WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENRITE AIDa7abf95e-d444-42da-e053-2995a90a88d32022-01-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENRITE AIDa7ac8b55-2758-400e-e053-2995a90a0eed2022-01-03WarningsExact identifier
unii: WK2XYI10QM
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: C151H8M554
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED3c8df1e5-61bc-4e70-b6b9-8973986ad5892021-12-21WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED859d7190-586f-4766-a7e7-9e800a72d58b2021-12-21WarningsExact identifier
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC0dec2df9-ba8b-4bc7-b617-773aa08f92732021-12-20WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200 mgIBUPROFENAllegiant Health8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad2021-12-06WarningsExact identifier
unii: WK2XYI10QM
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLCb2a14686-6083-46a1-885c-9f7c30e9c6472021-11-30WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200mgIBUPROFENAllegiant Healthf3f12b86-89dc-427e-a26f-728be6f73e7b2021-11-16WarningsExact identifier
unii: WK2XYI10QM
infants ibuprofenIBUPROFENH E B2c67fecb-2e69-44d6-8ab8-3251abae72a62021-11-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCc13455a3-307a-4fe1-e053-2a95a90adf8e2021-11-10WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENRITE AID CORPORATIONa7abac4c-7695-cfe8-e053-2a95a90ac1cd2021-10-30WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen bubblegumIBUPROFENGuardian Drug Company9cb92af9-a829-4f54-b8f5-4e5cb4f165b72021-10-13WarningsExact identifier
unii: WK2XYI10QM
basic care infants ibuprofenIBUPROFENAmazon.com Services LLC1b5b96cc-40d4-4fb8-b429-cc1a5076fa772021-10-08WarningsExact identifier
unii: WK2XYI10QM
rexall ibuprofenIBUPROFENDolgencorp, LLC869185d5-9f34-4d38-9551-dd0b4fc8557d2021-09-09WarningsExact identifier
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC1204267a-5505-4257-837b-8902b75713472021-09-07WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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