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 94 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2998b2bd-6208-4cb4-982b-0ffb97d7d75d2024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.68003c71-5959-476f-b252-1f131e9305e22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.b621b4cd-20db-44d8-b114-a977deea8eb42024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.c3a053ba-65fe-4540-9c81-29700cda5efa2024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2989afeb-8451-4a72-8456-195cd5117a412024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 1.25BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.17092ebf-8e57-4e1a-9bba-87a662c361c02024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.3ed3332e-f888-4b9c-aab7-99f8719b835e2024-12-05WarningsExact identifier
application number: M003
OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d05fbe85-26de-0d24-e053-2a95a90ab5cb2024-12-05WarningsExact identifier
application number: M003
OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.615921dd-46e5-403c-9ed3-f30beb0c0bb92024-12-05WarningsExact identifier
application number: M003
BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d334b7f0-01dc-7f59-e053-2a95a90a06b52024-12-05WarningsExact identifier
application number: M003
BLACK OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d3366750-18b8-1194-e053-2995a90a43592024-12-05WarningsExact identifier
application number: M003
OPS RANCH HAND ANTIBACTERIAL FOAMINGCHLOROXYLENOLArcher Manufacturing, Inc.d8187090-8423-062e-e053-2a95a90aad182024-12-05WarningsExact identifier
application number: M003
BLACK OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d335bf6d-dc75-bd80-e053-2a95a90abb562024-12-05WarningsExact identifier
application number: M003
OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d4c65a93-832a-6a8b-e053-2a95a90a77b82024-12-05WarningsExact identifier
application number: M003
alcohol pad 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.03a6e8d4-535d-b316-e063-6294a90aebf52024-12-04WarningsExact identifier
application number: M003
antiseptic towelette 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.e9f2a1f1-ceb6-2f20-e053-2a95a90a18db2024-12-04WarningsExact identifier
application number: M003
BobBarker antibacterial wrapped bodyBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa52024-12-04WarningsExact 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