FDA.reportPublic FDA data

NDC 70677-0153-01 - 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
70677-0153
Requested NDC
70677-0153-01
Package NDCs from labels
70677-0153-1, 70677-0153-01
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
70677-0153-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1181
70677-0153-1Ibuprofen Oral1 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0153IBUPROFEN 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
70677-0153-1ML - Milliliter70677-0153b4e8be0e-e5f7-4a79-9455-79aaa2fb6e4f12023-02-06

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 90 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ibuprofenIBUPROFENProficient Rx LP924d2dd0-3b7d-42ec-b617-86729dba2b952021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPe23eb275-ce0c-40ec-b809-a48c5e46c7ec2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: C151H8M554
IbuprofenIBUPROFENProficient Rx LP8813a8a4-ebbd-4204-88a3-600a92ea91702020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: C151H8M554
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: C151H8M554
Childrens IbuprofenIBUPROFENCVS Pharmacy60fd517d-608b-473e-8a44-eb98424599972020-10-22WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen IBIBUPROFENWINCO FOODS, LLC9d78644d-83c7-46d1-8156-0d76acb7c2992020-09-17WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen IBIBUPROFENWINCO FOODS, LLCee867519-227f-44ba-ba8b-2dbefcc9fc672020-09-17WarningsExact identifier
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC18e5eed7-d3be-4559-93ca-b40ee26c7bd82020-09-09WarningsExact identifier
unii: WK2XYI10QM
Basic Care Childrens IbuprofenIBUPROFENAmazon.com Services LLCd53cb3f1-6689-40dd-bdea-fad3a841d4822020-09-03WarningsExact identifier
unii: WK2XYI10QM
Dolex ChildrenIBUPROFENPharmadel LLCac3c264f-da37-a474-e053-2a95a90abdad2020-08-06WarningsExact identifier
application number: ANDA210602
unii: WK2XYI10QM
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: XF417D3PSL
IBUPROFENIBUPROFENBryant Ranch Prepack6d189e86-4c36-43f5-b406-a342458d41552020-05-27Exact identifier
unii: WK2XYI10QM
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLRite Aid Corporationa35f68f3-c7f8-a55f-e053-2a95a90a90472020-04-15WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENRite Aid Corporationaf68a4bf-bc49-40c7-812d-035eff474ed92020-04-03WarningsExact identifier
unii: WK2XYI10QM
JUNIOR STRENGTH ADVILIBUPROFENProficient Rx LP91fc4794-1880-460f-86dd-49d8c1e872bc2020-03-01WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENProficient Rx LP6d84ed87-b643-46e2-96d4-2052f41bd9362020-02-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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