FDA.reportPublic FDA data

Dermoplast First Aid

Product NDC
16864-670
11-digit product format
168640670
Labeler code
16864
Product ID
16864-670_4849d774-4d2d-2d24-e063-6294a90ab234
Type
HUMAN OTC DRUG
Nonproprietary name
BENZETHONIUM CHLORIDE and BENZOCAINE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Advantice Health, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-01
Substance
BENZETHONIUM CHLORIDE; BENZOCAINE
Active strength
2; 200 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Dermoplast First Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE2 mg/g
BENZOCAINE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049108Internal RxNorm lookup
1101914Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec93011d-7069-4021-8dd2-3d51eb6026e1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-670-01Dermoplast First Aid78 g in 1 CANSPRAY786

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-670-01GM - Gram16864-6702277d1c5-ea40-4e60-a385-a4efdded5a4b12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-670DERMOPLAST FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [ADVANTICE HEALTH, LLC]5Current NDC, Legacy NDC, 1 package rows20241215_ec93011d-7069-4021-8dd2-3d51eb6026e1.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 49 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuickMendBENZETHONIUM CHLORIDEEquibal, Inc.9b0c85a4-9727-4940-a934-0b81a7c938cf2025-12-17WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
application number: M003
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
application number: M003
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
application number: M003
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESFront Line Safety0e0ca589-834b-495b-e063-6394a90afbd02025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0dd88e-62eb-02c8-e063-6394a90a63d82025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0dfd48bb-3353-6062-e063-6294a90af6282025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0ef369-a0e7-5320-e063-6394a90a353f2025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e11238b-e5f2-075f-e063-6394a90aa8252025-12-15WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDEUniversal Distribution Center LLC53573a9c-bddc-49ea-931e-4779a20eb14f2025-12-15WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab2ced-cc6f-2c20-e063-6294a90a36d92025-12-14WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC45c3c6da-5217-5c2b-e063-6294a90a56d32025-12-12WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZERALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd1abf5aca-346f-0d18-e063-6294a90a93392025-12-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049108benzethonium Cl 0.2 % / benzocaine 20 % Topical SprayPSNec93011d-7069-4021-8dd2-3d51eb6026e16
1101914Dermoplast Antiseptic Anesthetic 0.2 % / 20 % Topical SprayPSNec93011d-7069-4021-8dd2-3d51eb6026e16
1101914benzethonium chloride 2 MG/ML / benzocaine 200 MG/ML Topical Spray [Dermoplast Antibacterial]SBDec93011d-7069-4021-8dd2-3d51eb6026e16
1049108benzethonium chloride 2 MG/ML / benzocaine 200 MG/ML Topical SpraySCDec93011d-7069-4021-8dd2-3d51eb6026e16
1049108benzethonium Cl 0.2 % / benzocaine 20 % Topical SpraySYec93011d-7069-4021-8dd2-3d51eb6026e16
1101914Dermoplast Antibacterial (benzethonium chloride 0.2 % / benzocaine 20 % ) Topical SpraySYec93011d-7069-4021-8dd2-3d51eb6026e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-670-011686406700178 g in 1 CAN (16864-670-01) 78 g2010-01-010000-00-00NoNoCurrent