FDA.reportPublic FDA data

NDC 51688-9629 - 15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE

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
51688-9629
Package NDCs from labels
51688-9629-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2012-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Epinephrine - Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.2012-07-23MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT815858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394RO15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X415858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI20098715858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OK15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA7415858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R15858-21 SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE () C47916 [SMITHS MEDICAL ASD, INC.]1

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 31 of 82 · 1,630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
EPINEPHRINEEPINEPHRINEHenry Schein, Inc.3b1ac82f-6920-4e40-a77e-598398679f2d2025-10-31Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.009bef3c-e8ac-46be-b564-a2556adf00812025-10-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
epinephrineEPINEPHRINEAmneal Pharmaceuticals LLCc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0922025-10-31Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc3c0f567f-b7f8-4ee8-bfb2-61cd825504982025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cold and Cough 4 KidsONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.e06599ca-fc94-4b2c-829e-f3d4ec866ed62025-10-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
unii: 451W47IQ8X
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc496ccd9e-d1c3-4b5a-93b6-0c457faa15892025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8

Reported adverse events (FAERS/openFDA)#

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