FDA.reportPublic FDA data

NDC 83090-001-01 - NA

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
83090-001
Requested NDC
83090-001-01
Package NDCs from labels
83090-001-01, 83090-001-10
Manufacturer
Sintetica US LLC | SINTETICA SA
Effective date
2022-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NA - Sintetica US LLC | SINTETICA SASintetica US LLC | SINTETICA SA2022-11-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83090-001-102026-01-29C16284748780-149896155-bf71-586f-e063-e6dba90add90LIDOCAINE HYDROCHLORIDE INJECTION, USP 1% LIDOCAINE HYDROCHLORIDE INJECTION, USP 2% For Infiltration and Nerve Block Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83090-001-01NA2 mL in 1 AMPULEINJECTION, SOLUTION21
83090-001-10NA10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83090-001NA (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [SINTETICA US LLC]1Legacy NDC, 2 package rows20221217_aa3e688a-308c-4a82-a268-28ccf1677c55.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83090-001-10ML - Milliliter83090-0016aae6623-3d22-429b-95bd-711e27578c7a12024-03-12

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 49 of 56 · 1,112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miranda Castros Healing Gel for Bites and StingsCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS.OHM PHARMA INC.8e06aaa4-c177-45cf-9d8d-e0099de256682022-12-02WarningsExact identifier
unii: 451W47IQ8X
Yonis BlissCHAMOMILLA, NATRUM MURIATICUMBrookhaus Essentials LLCea4091d6-d295-41a0-aae5-68f3c260e1102022-11-30WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: 451W47IQ8X
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: 451W47IQ8X
0d18f291-3a92-421e-8841-6be743b1f154aa3e688a-308c-4a82-a268-28ccf1677c552022-11-15Warnings, Adverse reactionsExact identifier
spl id: 0d18f291-3a92-421e-8841-6be743b1f154
spl set id: aa3e688a-308c-4a82-a268-28ccf1677c55
Multiple Electrolytes pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLC84221110-b3f1-42f4-800c-ad1d3b330e9e2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Multiple Electrolytes pH 5.5SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLCcf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRUM MURIATICUMHahnemann Laboratories, INC.ecf06f13-012c-212d-e053-2995a90a71982022-11-08Exact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEB. Braun Medical Inc.e0e479e6-4c94-44d0-8074-d0ee7b2bde222022-10-13Warnings, Adverse reactionsExact identifier
rxcui: 1737566
unii: EC2CNF7XFP
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.fecd1797-7757-4da8-b3a1-24b2586342432022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 1737761
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.8ae0656c-36fb-48fb-886b-1031d11da5522022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 1737757
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.deec52c7-ebcf-422e-beab-bc1df2fe30cb2022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 1737568
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLC6a1322c7-7767-4569-aa22-9d2e363312832022-08-30WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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