FDA.reportPublic FDA data

Dermoplast Kids

Product NDC
16864-660
11-digit product format
168640660
Labeler code
16864
Product ID
16864-660_29144767-5d80-020f-e063-6394a90a9deb
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
2022-03-01
Substance
BENZETHONIUM CHLORIDE; BENZOCAINE
Active strength
2; 150 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
2026-12-31
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 Kids
Brand name suffix
First Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE2 mg/g
BENZOCAINE150 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
2609039Internal RxNorm lookup
2627727Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29a18018-5214-4080-ac40-e646319e95ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-660-01Dermoplast KidsFirst Aid57 g in 1 CANSPRAY573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-660DERMOPLAST KIDS FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [ADVANTICE HEALTH, LLC.]3Current NDC, 1 package rows20241215_29a18018-5214-4080-ac40-e646319e95ce.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 27 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diabetic First Aid GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELavior Pharma Inc.bda875e6-06bd-930f-e053-2995a90ab1972026-03-26WarningsExact identifier
application number: M003
Povidone Iodine Prep PadANTISEPTICDynarex Corporation81b475e8-8da4-7b15-e053-2991aa0a66292026-03-25WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4dde3373-1c75-a815-e063-6294a90aa5572026-03-25WarningsExact identifier
application number: M003
Los Poblanos Lavender Hand SanitizerALCOHOLSombra Cosmetics Inc.4ddef71b-f5b8-57f5-e063-6294a90a78a32026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.48786094-aa70-d0ca-e063-6394a90acd882026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL GELDongyang Loulee Cosmetics Co.,Ltd.487c4724-b618-a071-e063-6394a90aa7822026-03-25WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLMY IMPORTS USA LLC4dbe636b-f376-7e30-e063-6394a90a722b2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLMY IMPORTS USA LLC4dbe7020-e302-8706-e063-6394a90abe7c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLMY IMPORTS USA LLC4dbe79d2-ee73-a8ed-e063-6394a90a7db52026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLMY IMPORTS USA LLC4dbe8d3f-afac-cc82-e063-6294a90ae3092026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLMY IMPORTS USA LLC4dcfcd41-b93f-accf-e063-6394a90a963d2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLMY IMPORTS USA LLC4dd00a64-c0bf-cf7d-e063-6394a90a76922026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLMY IMPORTS USA LLC4dd010e2-7bcf-666f-e063-6294a90a4f3c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
application number: M003
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
application number: M003
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2609039benzethonium chloride 0.2 % / benzocaine 15 % Topical SprayPSN29a18018-5214-4080-ac40-e646319e95ce3
2627727Dermoplast Antiseptic Kids 0.2 % / 15 % Topical SprayPSN29a18018-5214-4080-ac40-e646319e95ce3
2627727benzethonium chloride 2 MG/ML / benzocaine 150 MG/ML Topical Spray [Dermoplast Antibacterial]SBD29a18018-5214-4080-ac40-e646319e95ce3
2609039benzethonium chloride 2 MG/ML / benzocaine 150 MG/ML Topical SpraySCD29a18018-5214-4080-ac40-e646319e95ce3
2609039benzethonium chloride 0.2 % / benzocaine 15 % Topical SpraySY29a18018-5214-4080-ac40-e646319e95ce3
2627727Dermoplast Antibacterial Kids (benzethonium chloride 0.2 % / benzocaine 15 % ) Topical SpraySY29a18018-5214-4080-ac40-e646319e95ce3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16864-660-011686406600157 g in 1 CAN (16864-660-01) 57 g2022-03-01NoNoCurrent