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 9 of 116 · 2,312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c2026-06-24Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD54e83df5-bbeb-d068-e063-6394a90ad5132026-06-23WarningsExact identifier
unii: 85H0HZU99M
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Marcaine SpinalBUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.9679cc05-2f8a-4e88-53b5-6e9122c8b8c02026-06-23Warnings, Adverse reactionsExact identifier
application number: NDA018692
ndc (package): 0409-1761-62
ndc (product): 0409-1761
rxcui: 1724792
rxcui: 1724784
spl id: ef77810e-d05c-4501-9512-10dbe0bc7f00
spl set id: 9679cc05-2f8a-4e88-53b5-6e9122c8b8c0
unii: 7TQO7W3VT8
BUPIVACAINE HClBUPIVACAINE HCLHF Acquisition Co LLC, DBA HealthFirste391f807-7699-6d82-e053-2a95a90ab6412026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsExact identifier
unii: 85H0HZU99M
LIDOCAINE HCl AND EPINEPHRINELIDOCAINE HCL AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta09613b2-4337-5b52-e053-2995a90ab74b2026-06-19Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
unii: V13007Z41A
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
unii: V13007Z41A
Povidone-Iodine Scrub SolutionPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdefa7f9f6-ae02-4104-bb9e-16e1ffd2be7a2026-06-17WarningsExact identifier
unii: 85H0HZU99M
PVP Scrub SolutionPOVIDONE IODINEMcKesson Medical-Surgical Inc.49db333e-36e1-1965-e054-00144ff8d46c2026-06-17WarningsExact identifier
unii: 85H0HZU99M
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Primatene MistEPINEPHRINE INHALATIONArmstrong Pharmaceuticals, Inc.95011f7e-51be-4851-80a6-a7e9c6cad82a2026-06-16WarningsExact identifier
unii: YKH834O4BH
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsExact identifier
unii: V13007Z41A
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53f9c99a-0f20-0358-e063-6394a90af4e02026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448c76a-2ecb-9402-e063-6294a90a6ad72026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 451W47IQ8X
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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