FDA.reportPublic FDA data

NDC 51688-8367 - A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY

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
51688-8367
Package NDCs from labels
51688-8367-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date
2012-11-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
A2503-18 SINGLE SHOT EPIDURAL 18G TUOHYSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.2012-11-29MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI200987A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [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 90 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POVIDONE IODINE PREP PAD SterilePOVIDONE-IODINEJianerkang Medical Co., Ltdac3aa401-a124-4eb7-9598-119be0f24ddd2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdccf3b4c4-2c33-4fae-9916-1149d40c78762023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine Prep Solution SterilePOVIDONE-IODINEJianerkang Medical Co., Ltd95f8489e-05fa-4f0f-acd6-0c426009080e2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdcb1aa198-c72a-4cda-b268-dc8c9c7265942023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd01bcad25-efdc-426f-ba91-acbdff8421b32023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdbbe0d44d-8752-44e6-acad-f8deeebdbf172023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd5a33ec74-1e65-4f16-a8f7-230d7e818dbd2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltddeea0412-266d-46a5-a3ec-fa4400fcdc0a2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ScrubPOVIDONE IODINEJianerkang Medical Co., Ltd7ece9211-e9ee-43bc-b006-469ea3f4c09e2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Prep PadPOVIDONE-IODINECardinal Health 200, Inc.06c8a6f6-2fc8-4292-a3b5-6311a918a5212023-10-23WarningsExact identifier
unii: 85H0HZU99M
Theraworx Pain Relief Roll- On- LidocaineLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.b4ce3876-f9e3-43ca-810b-75fbe6f887b62023-10-23WarningsExact identifier
unii: V13007Z41A
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltdf231a572-a99d-4146-afa3-e73ea1cee0272023-10-22WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltd42778607-6170-4a5e-94d0-5e6cd064eec62023-10-22WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
unii: 85H0HZU99M
Numquick Topical AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.3f64cbd3-6745-4397-9767-3adc3b301e0e2023-10-19WarningsExact identifier
unii: V13007Z41A
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
unii: EC2CNF7XFP
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
unii: V13007Z41A
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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