FDA.reportPublic FDA data

NDC 55553-482 - ACL11CH NERVE BLOCK

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
55553-482
Package NDCs from labels
55553-482-02
Manufacturer
Smiths Medical ASD, Inc. | CareFusion 213 LLC
Effective date
2014-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACL11CH NERVE BLOCK - Smiths Medical ASD, Inc. | CareFusion 213 LLCSmiths Medical ASD, Inc. | CareFusion 213 LLC2014-04-14MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54365-400-11ACL11CH NERVE BLOCK3 mL in 1 APPLICATORSOLUTION3 mL20 mg in 1mL1
55553-482-02ACL11CH NERVE BLOCK1 in 1 PACKAGE, COMBINATIONKIT11
55553-482-02ACL11CH NERVE BLOCK30 in 1 CASEKIT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55553-482ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]13 package rows20140415_57a2935b-5741-43ce-9833-1de31eb02011.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8EACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]1
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ACL11CH NERVE BLOCK () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RACL11CH NERVE BLOCK () 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 46 of 47 · 932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEVistaPharm, LLC7fb18b56-a76d-4f15-9438-c941def76fdb2022-01-19Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Periogard Alcohol FreeCHLORHEXIDINE GLUCONATEColgate Oral Pharmaceuticals, Inc.4993fc4a-bbe2-5ccb-de4d-44d73d484d392021-10-14Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Rite Aidbe5df410-f893-a68f-e053-2995a90a18582021-03-25WarningsExact identifier
unii: MOR84MUD8E
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Periogard Alcohol FreeCHLORHEXIDINE GLUCONATEColgate Oral Pharmaceuticals, Inc.1aaad8d7-b6be-43a2-b3a2-12501a2fcdca2020-11-18Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Dyna-Hex 2CHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.36e6abcb-d792-3ef4-e054-00144ff8d46c2020-10-13WarningsExact identifier
unii: MOR84MUD8E
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a4cfe-88e2-0a10-e054-00144ff88e882020-03-23Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.47057d87-e142-222a-e054-00144ff8d46c2020-03-23Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Provon Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2%Gojo Industries, Inc.36803a5b-3075-5d5b-e054-00144ff8d46c2019-06-19WarningsExact identifier
unii: MOR84MUD8E
Antimicrobial Skin CleanserCHLORHEXIDINE GLUCONATE 2% SOLUTIONGojo Industries, Inc.759beac3-6fc8-40c6-e053-2a91aa0aab572019-06-18WarningsExact identifier
unii: MOR84MUD8E
Purell Antimicrobial FoamCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.6e0f3d2f-7834-68a0-e053-2991aa0ab4532019-06-18WarningsExact identifier
unii: MOR84MUD8E

Reported adverse events (FAERS/openFDA)#

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