FDA.reportPublic FDA data

ProStat Protective Coating Bandage First Aid

Product NDC
58228-0102
11-digit product format
582280102
Labeler code
58228
Product ID
58228-0102_8af1b91c-d74f-4ba4-9543-2a176ed3631a
Type
HUMAN OTC DRUG
Nonproprietary name
benzethonium chloride and benzocaine
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
ProStat First Aid
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-18
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE; BENZOCAINE
Active strength
170 mg/85g; mg/85g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58228-0102-32019-11-27C16284748780-19855e2a2-4512-60a7-e053-dbdaa90a05bdProStat Bandage Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-0102-3ProStat Protective Coating Bandage First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY852

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744PROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5PROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
BENZETHONIUMACTIVE MOIETY1VU15B70BPPROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5PROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
BUTANEINACTIVE INGREDIENT6LV4FOR43RPROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BPROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
ISOBUTANEINACTIVE INGREDIENTBXR49TP611PROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2
PROPANEINACTIVE INGREDIENTT75W9911L6PROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-0102PROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2Legacy NDC, 1 package rows20140226_25e25261-71e1-4fc0-98c6-c1deb9e6b6f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049110benzethonium Cl 0.2 % / benzocaine 3.2 % Topical SprayPSN25e25261-71e1-4fc0-98c6-c1deb9e6b6f92
1049110benzethonium chloride 2 MG/ML / benzocaine 32 MG/ML Topical SpraySCD25e25261-71e1-4fc0-98c6-c1deb9e6b6f92
1049110benzethonium Cl 0.2 % / benzocaine 3.2 % Topical SpraySY25e25261-71e1-4fc0-98c6-c1deb9e6b6f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58228-0102-35822801020385 g in 1 BOTTLE, SPRAY85 gHistorical