FDA.reportPublic FDA data

NDC 51688-9282 - A3265-18 SINGLE SHOT EPIDURAL

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
51688-9282
Package NDCs from labels
51688-9282-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date
2016-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
A3265-18 SINGLE SHOT EPIDURALSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd.2016-07-08MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AA3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XA3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4
LIDOCAINEACTIVE MOIETY98PI200987A3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4
SODIUM CATIONACTIVE MOIETYLYR4M0NH37A3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBA3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XA3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IA3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RA3265-18 SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]4

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 67 of 88 · 1,752 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirstc1735498-0721-687c-e053-2a95a90a47f42024-02-19Warnings, Adverse reactionsExact identifier
rxcui: 1737562
unii: V13007Z41A
11681168 BURN SPRAYDynarex Corporation1183a4f5-f875-dfb0-e063-6394a90af35f2024-02-16WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0050d05a-b8e9-c544-e063-6294a90a02432024-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISThe Magni Companyb09bf037-703f-4c22-8535-b33d586ebefa2024-02-08WarningsExact identifier
unii: 451W47IQ8X
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
unii: V13007Z41A
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
unii: V13007Z41A
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.47cb6921-5d82-4123-a9e0-0b05d4dcb5b22024-02-07WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
unii: V13007Z41A
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mirakel Pain Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
unii: V13007Z41A
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst8c63be55-5de4-7f72-e053-2995a90a102e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999dd95d-87fe-12c0-e053-2995a90aa9f72024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1010033
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4bf5905-add7-1cb0-e053-2995a90a73342024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4c0df51-cc37-323d-e053-2995a90a154a2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals7a664a34-19fd-4a7b-ab4d-11299b32999e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticalsfd6343a9-15a6-4894-b51f-122e4d6dbe792024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESeton Pharmaceuticals1c0abe84-5404-404e-b882-e910e4d43ffb2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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