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 88 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAurohealth LLC3b0e77a1-b49d-4c67-81dd-66450dabcf3b2022-03-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC0ade8ee2-7c74-4b05-925e-d92742fc2b902022-03-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLCcf6fbf3b-a0f3-4e08-a981-d183fa2857582022-03-03WarningsExact identifier
unii: WK2XYI10QM
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLCa656f8b0-8cb4-4802-b8d3-7b95c0265d562022-02-21WarningsExact identifier
unii: WK2XYI10QM
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC91723661-d0bb-4498-ac59-59bbdc3342302022-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAurohealth LLC6adf9292-b4af-4cb4-99f3-dda03734570a2022-01-21WarningsExact identifier
unii: WK2XYI10QM
Pain Relief - Ibuprofen 200 mgIBUPROFENHealth Pharma USA LLCd60a6a11-8c06-cede-e053-2a95a90af7f92022-01-20WarningsExact identifier
unii: WK2XYI10QM
Concentrated ibuprofen infantsIBUPROFENWal-Mart Stores, Inc.00b7fc71-8cf0-4c12-a479-146408f7f91b2022-01-11WarningsExact identifier
unii: WK2XYI10QM
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
TreprostinilTREPROSTINILDr.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
rxcui: 197803
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

Reported adverse events (FAERS/openFDA)#

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