FDA.reportPublic FDA data

NDC 70677-0152-01 - Ibuprofen Oral

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
70677-0152
Requested NDC
70677-0152-01
Package NDCs from labels
70677-0152-1, 70677-0152-01
Manufacturer
Strategic Sourcing Services | AptaPharma Inc.
Effective date
2022-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)Strategic Sourcing Services | AptaPharma Inc.2022-08-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0152-1Ibuprofen Oral1 in 1 CARTONSUSPENSION11
70677-0152-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0152IBUPROFEN ORAL (IBUPROFEN ORAL) SUSPENSION [STRATEGIC SOURCING SERVICES]1Current NDC, Legacy NDC, 2 package rows20220811_a3062142-db0e-4758-a762-2b2bb05670b1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0152-1ML - Milliliter70677-0152bb59880f-140d-48e5-abd1-1bd53821bd8712023-02-06

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 56 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care ibuprofenIBUPROFENAmazon.com Services LLC25bc5cc2-9b6a-47e4-8b3d-2bb370907b612025-03-20WarningsExact identifier
unii: WK2XYI10QM
basic care ibuprofenIBUPROFENAmazon.com Services LLCcd15159a-9ed5-453a-9ad4-0c9688204c822025-03-19WarningsExact identifier
unii: WK2XYI10QM
equate ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENWal-Mart Stores Ince36957ed-653c-465f-8150-7d6073e1376f2025-03-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.ce5b0429-bbe1-47a4-af5e-0159d3cfd2c32025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCare One (Retail Business Services, LLC.)a6ce7484-7a32-4985-80bc-883c31be35252025-03-12WarningsExact identifier
unii: WK2XYI10QM
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
Sudafed PE Head Congestion Plus PainIBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC76513fb2-7323-4f1f-8a10-92f8f603cf972025-03-10WarningsExact identifier
unii: WK2XYI10QM
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
Redicare Ibuprofen 200mgIBUPROFEN 200MGRedicare LLC2f0db953-33e2-1729-e063-6294a90af0742025-03-04Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
LEADER CHILDRENS IBUPROFENIBUPROFENCardinal Health 110, LLC. dba Leader913a4bd0-0784-45b4-b05e-3e7c016bbb862025-03-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
equate ibuprofenIBUPROFENWal-Mart Stores Inc2daee8c1-d05e-406b-af65-b81bbbaa244d2025-03-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
ibuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd02889717-204c-463b-8506-4c5cf18c77d32025-03-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.65ec0f85-7ca3-4adc-b152-a0ae2fd0692f2025-02-27WarningsExact identifier
unii: WK2XYI10QM
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
AeroTab IbuprofenIBUPROFEN TABLETAero Healthcareddd0f7fb-ae4b-c584-e053-2a95a90a09842025-02-26WarningsExact identifier
unii: WK2XYI10QM
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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