FDA.reportPublic FDA data

Your Logo Here Burn First Aid

Product NDC
52982-101
11-digit product format
529820101
Labeler code
52982
Product ID
52982-101_2cc572f5-040c-0514-e063-6294a90a5d51
Type
HUMAN OTC DRUG
Nonproprietary name
benzocaine, benzethonium chloride, and menthol
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Dixon Investments, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-05
Substance
BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL
Active strength
170; 8500; 281 mg/85g; mg/85g; mg/85g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Your Logo Here Burn First Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE170 mg/85g
BENZOCAINE8500 mg/85g
MENTHOL281 mg/85g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPH41D05744, U3RSY48JW5, L7T10EIP3A
Rxcui1192516

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52982-101-012023-01-19C16284748780-19855d018-ea89-cd31-e053-dbdaa90ab51aYOUR LOGO HERE BURN SPRAY
52982-101-032023-01-19C16284748780-19855d018-ea89-cd31-e053-dbdaa90ab51aYOUR LOGO HERE BURN SPRAY
52982-101-012019-11-27C16284748780-19855d018-ea89-cd31-e053-dbdaa90ab51aYOUR LOGO HERE BURN SPRAY
52982-101-032019-11-27C16284748780-19855d018-ea89-cd31-e053-dbdaa90ab51aYOUR LOGO HERE BURN SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52982-101-01Your Logo Here Burn First Aid14.2 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY14.27
52982-101-03Your Logo Here Burn First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY857

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
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
MENTHOLACTIVE INGREDIENTL7T10EIP3APROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
MENTHOLACTIVE INGREDIENTL7T10EIP3AYOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
BENZETHONIUMACTIVE MOIETY1VU15B70BPPROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BENZETHONIUMACTIVE MOIETY1VU15B70BPYOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
BENZOCAINEACTIVE MOIETYU3RSY48JW5PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BENZOCAINEACTIVE MOIETYU3RSY48JW5YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
MENTHOLACTIVE MOIETYL7T10EIP3APROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
MENTHOLACTIVE MOIETYL7T10EIP3AYOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
BUTANEINACTIVE INGREDIENT6LV4FOR43RYOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
BUTANEINACTIVE INGREDIENT6LV4FOR43RPROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
ISOBUTANEINACTIVE INGREDIENTBXR49TP611YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
ISOBUTANEINACTIVE INGREDIENTBXR49TP611PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
PROPANEINACTIVE INGREDIENTT75W9911L6YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]4
PROPANEINACTIVE INGREDIENTT75W9911L6PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744AEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5AEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AAEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPAEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5AEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AAEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
BUTANEINACTIVE INGREDIENT6LV4FOR43RAEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40AEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
ISOBUTANEINACTIVE INGREDIENTBXR49TP611AEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1
PROPANEINACTIVE INGREDIENTT75W9911L6AEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52982-101YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]7Current NDC, Legacy NDC, 2 package rows20250130_57d1a917-d635-4e7b-a49a-6b3d175af326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SprayPSN57d1a917-d635-4e7b-a49a-6b3d175af3267
1192516benzethonium chloride 2 MG/ML / benzocaine 100 MG/ML / menthol 3.3 MG/ML Topical SpraySCD57d1a917-d635-4e7b-a49a-6b3d175af3267
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SpraySY57d1a917-d635-4e7b-a49a-6b3d175af3267
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
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SprayPSNb780da38-8568-43e1-ab4a-5b69e4f55b191
1192516benzethonium chloride 2 MG/ML / benzocaine 100 MG/ML / menthol 3.3 MG/ML Topical SpraySCDb780da38-8568-43e1-ab4a-5b69e4f55b191
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SpraySYb780da38-8568-43e1-ab4a-5b69e4f55b191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52982-101-015298201010114.2 g in 1 BOTTLE, SPRAY (52982-101-01) 14.2 g2013-04-05NoNoCurrent
52982-101-035298201010385 g in 1 BOTTLE, SPRAY (52982-101-03) 85 g2013-04-05NoNoCurrent