Your Logo Here Burn First Aid

Product NDC
52982-101
Requested package NDC
52982-101-01
11-digit product format
529820101
Labeler code
52982
Product ID
52982-101_5ccd9f43-9002-67b5-e063-6294a90a13f8
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
Marketing end
2027-09-30
Substance
BENZOCAINE; BENZETHONIUM CHLORIDE; MENTHOL
Active strength
8500; 170; 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
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Your Logo Here Burn First Aid

Active Ingredients#

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

FDA-Initiated Inactive NDC Indexing#

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

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 92 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
application number: M003
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd98812b-017a-2cd2-e053-2a95a90a38ce2024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLMY IMPORTS LLCd4d72406-067d-1f67-e053-2995a90a1a9f2024-12-18WarningsExact identifier
application number: M003
AMORAY 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORT USA INC7114b527-106b-4629-867c-63dba13635a22024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7e7f8-7c8a-2b51-e053-2995a90a63d02024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMy Imports USA, LLCd4d77ec3-4930-74f0-e053-2a95a90a962a2024-12-18WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7adaf-c0fd-82fa-e053-2995a90ab9f62024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA, LLCde47bf08-f64e-781d-e053-2a95a90ab08f2024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d80ae4-3fba-4605-e053-2a95a90a21192024-12-18WarningsExact identifier
application number: M003
American Red Cross 50% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCde47a879-9cd0-5fbb-e053-2a95a90a1fba2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
application number: M003
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
application number: M003
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
application number: M003
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
application number: M003
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
application number: M003
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact identifier
application number: M003

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 startMarketing endSampleExclude flagStatus
52982-101-015298201010114.2 g in 1 BOTTLE, SPRAY (52982-101-01) 14.2 g2013-04-052027-09-30NoNoHistorical