FDA.reportPublic FDA data

NDC 51688-9397 - 49662-25 SPINAL 25G PENCIL POINT

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
51688-9397
Package NDCs from labels
51688-9397-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2016-08-02
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.2016-08-02MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT849662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394RO49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X449662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI20098749662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OK49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA7449662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0R49662-25 SPINAL 25G PENCIL POINT () 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 44 of 116 · 2,312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
epinephrineEPINEPHRINEAmneal Pharmaceuticals LLCc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0922025-10-31Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.f0617ab8-555f-4cbe-9795-c922f5ef176e2025-10-31Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c2025-10-31Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
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
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.e1badbba-59af-e451-e053-2a95a90a49f82025-10-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lipoflavonoid Ear Pain Kids Relief DropsLIPOFLAVONOID EAR PAIN KIDS RELIEF DROPSClarion Brands LLC4265361b-5526-c3e0-e063-6394a90a17772025-10-30WarningsExact identifier
unii: V13007Z41A
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
WorkvieLIDOCAINE HCL, MENTHOLMarketites LLCaebaffb5-58dd-ebd5-e053-2a95a90a14ed2025-10-29WarningsExact identifier
unii: V13007Z41A
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
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC.42531a38-7cff-de16-e063-6394a90a18d82025-10-29Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
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

Reported adverse events (FAERS/openFDA)#

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