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 93 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
IBUPROFENIBUPROFEN 200MGADVANCED FIRST AID, INC.564e9910-b491-4129-a4f1-68216267623b2018-07-23WarningsExact identifier
unii: WK2XYI10QM
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU
Ibuprofen ChildrensIBUPROFENH E B0a9a54ce-572f-4a96-922f-cc136d2d4aad2018-06-07WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENBreeden Brothers, LLCe4314153-479d-4c0f-ba49-4d4efded304b2018-04-06WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen Fast relief medicine for painIBUPROFEN 200 MGAllegiant Healthdd63b011-0573-4374-9669-8d29146e5fc92017-11-17WarningsExact identifier
unii: WK2XYI10QM
Sound Body IbuprofenIBUPROFEN 200 MGAllegiant Health73af6385-3081-49cc-83de-f872a47c31dc2017-11-15WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200mgIBUPROFEN 200MGAthlete's Needs, Inc.2db10105-6fd3-420d-8889-7cfd6f396e5f2017-11-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPuraCap Pharmaceutical LLCacc4cbc8-085d-42f3-ad93-113e0b55631c2017-11-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS PHARMACY, INC.cdd5a402-df90-4a16-a38c-78eab71899982017-11-09WarningsExact identifier
unii: WK2XYI10QM
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fast Pain ReliefIBUPROFENHealthLife of USA LLCa3fcd34a-6aa9-477c-bbfb-2f6b36e06b652017-06-05WarningsExact identifier
unii: WK2XYI10QM
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Dye Free IbuprofenIBUPROFENBreeden Brothers, LLCba106f6f-2c6b-4c98-a10e-d27622b08b252017-02-15WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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