ProStat Burn First Aid

Product NDC
58228-0105
11-digit product format
582280105
Labeler code
58228
Product ID
58228-0105_7518092e-2c65-42be-bf2e-8a665defe6c1
Type
HUMAN OTC DRUG
Nonproprietary name
benzethonium chloride, benzocaine, and menthol
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
ProStat First Aid
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-18
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL
Active strength
170 mg/85g; 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
58228-0105-32019-11-27C16284748780-19855e2a2-36db-60a7-e053-dbdaa90a05bdProStat Pain Relieving Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-0105-3ProStat Burn First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY854

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
MENTHOLACTIVE INGREDIENTL7T10EIP3APROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BENZETHONIUMACTIVE MOIETY1VU15B70BPPROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BENZOCAINEACTIVE MOIETYU3RSY48JW5PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
MENTHOLACTIVE MOIETYL7T10EIP3APROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BUTANEINACTIVE INGREDIENT6LV4FOR43RPROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
ISOBUTANEINACTIVE INGREDIENTBXR49TP611PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
PROPANEINACTIVE INGREDIENTT75W9911L6PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-0105PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4Legacy NDC, 1 package rows20140307_0d490ebb-adc9-4f06-8e23-992abafbf151.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SprayPSN0d490ebb-adc9-4f06-8e23-992abafbf1514
1192516benzethonium chloride 2 MG/ML / benzocaine 100 MG/ML / menthol 3.3 MG/ML Topical SpraySCD0d490ebb-adc9-4f06-8e23-992abafbf1514
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SpraySY0d490ebb-adc9-4f06-8e23-992abafbf1514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58228-0105-35822801050385 g in 1 BOTTLE, SPRAY85 gHistorical