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 82 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense ibuprofenIBUPROFENL. Perrigo Company9164f7e8-81a0-4b71-a2b3-111b2a7541bb2023-07-12WarningsExact identifier
unii: WK2XYI10QM
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALS, INC3529be10-0004-4628-9ca1-67a8acd86b512023-07-05Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)eaa0a286-a0f0-4979-8af3-c5f4194283fd2023-06-22WarningsExact identifier
unii: WK2XYI10QM
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
Rexall IbuprofenIBUPROFENDolgencorp, LLCd2dc2f71-c0cb-4e6d-85b9-fcf386e207a02023-06-06WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPe4bb22bb-6df6-4016-a023-0b454df9fb0b2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
LY-COANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.47140966-5b49-432d-bf35-bcae14f420822023-06-01WarningsExact identifier
unii: XF417D3PSL
Lyme and Co-Infection NosodeANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BABESIA MICROTI, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.f6186157-256f-4454-b122-f7665e3286f42023-06-01WarningsExact identifier
unii: XF417D3PSL
basic care ibuprofenIBUPROFENAmazon.com Services LLC3329f487-675d-440c-b7c5-d17a2b0242752023-05-31WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENBluePoint Laboratoriesd71acfe2-4643-f50b-e053-2a95a90add8b2023-05-31WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DG health dual pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Inc464d436a-79b0-45b4-8b5f-51dc2de2d8e42023-05-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7d544d8e-fa76-461f-9417-5f1873912eac2023-05-15WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Equate IbuprofenIBUPROFENWal-Mart Stores Inc153bc4ac-427d-426a-9bb8-665487e4b1692023-04-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLC1889faea-24a3-45ea-92de-8dc76b9ed5b42023-04-25WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRITE AID CORPORATIONde158883-1175-18fc-e053-2995a90a3c962023-04-12WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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