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 87 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENDOLGENCORP, INC.df321783-73cb-55bf-e053-2a95a90a4ce22022-07-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPb7565aac-a928-4116-b9af-cf636da4537c2022-07-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
unii: K679OBS311
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
unii: K679OBS311
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEAurohealth LLC21c1f5c5-19fa-4a59-bad3-ea85fd37471b2022-06-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCARDINAL HEALTHdfbbde4f-633d-6d57-e053-2a95a90ad82f2022-05-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC7779c369-50bf-4cde-9015-ff3fb35e128e2022-05-16WarningsExact identifier
unii: WK2XYI10QM
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
IbuprofenIBUPROFENProficient Rx LPd2c7f045-e70c-4e2b-b2e0-d81a271d0a042022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENJones Healthcare Group - Packaging Services, Inc6419cc78-27d4-7713-e053-2a91aa0a5a102022-04-29WarningsExact identifier
unii: WK2XYI10QM
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
IbuprofenIBUPROFENProficient Rx LP2dc3108f-d917-40c6-865d-c900cf055d1c2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENProficient Rx LP798d33b0-5d7a-4445-8a51-2a3d336f744a2022-04-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LP444b2ea0-ec42-4bcf-b8d2-38b4b297ada02022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENAurohealth LLC1100648c-6b9f-49c9-94d0-c40f24fe5c272022-03-23WarningsExact identifier
unii: WK2XYI10QM
basic care ibuprofenIBUPROFENAmazon.com Services LLC9bbbedb3-e0b2-4645-8105-98800096cfed2022-03-09WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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