FDA.reportPublic FDA data

Antiseptic

Product NDC
61010-5300
11-digit product format
610105300
Labeler code
61010
Product ID
61010-5300_10d37ff3-97c6-9f55-e063-6294a90a656b
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, benzocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-15
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
1; 50 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
Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/g
BENZOCAINE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1245229Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
458e65f2-826d-4550-8c7d-17add2d7ba9aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61010-5300-02024-02-1361010-5300, Cut and Scrape Antiseptic
61010-5300-22024-02-1361010-5300, Cut and Scrape Antiseptic
61010-5300-02024-01-3061010-5300, Cut and Scrape Antiseptic
61010-5300-22024-01-3061010-5300, Cut and Scrape Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5300-0Antiseptic60 g in 1 BOTTLE, SPRAYSPRAY604
61010-5300-2Antiseptic90 g in 1 BOTTLE, SPRAYSPRAY904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W7ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]2
benzocaineACTIVE INGREDIENTU3RSY48JW5ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]2
benzalkoniumACTIVE MOIETY7N6JUD5X6YANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]2
benzocaineACTIVE MOIETYU3RSY48JW5ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5300ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 2 package rows20240214_458e65f2-826d-4550-8c7d-17add2d7ba9a.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 36 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDEGrocery Outlet, Inc.3dffcbdb-f9cd-bfdd-e063-6394a90a35a42026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHARRIS TEETERa90eba84-fc0f-48d7-b94e-1507f981800d2026-02-04WarningsExact identifier
application number: M003
91% ISOPROPYL ALCOHOL91% ISOPROPYL ALCOHOLHy-Vee, Inc.497471bb-541c-f945-e063-6294a90adbb22026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHy-Vee, Inc.48316d8f-595b-7087-e063-6294a90a29ce2026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLHy-Vee, Inc.4831eecf-d111-6f17-e063-6394a90a4ab92026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
RoyceDerm Antibacterial Body WashBENZALKONIUM CHLORIDE 0.13%RoyceDerm LLC4a0c66b1-5a6f-b9b9-e063-6294a90a3d772026-02-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Sweet Pea GardenALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e7ce12-78a6-f86c-e063-6394a90a79e62026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Jasmine JewelALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e891ac-fa83-f687-e063-6294a90a52552026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer RosebudALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e8bca0-e872-2585-e063-6294a90a34b22026-02-03WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS Pharmacy, Inc.5e3efd36-f11e-4e50-8936-fc54e67eebe52026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLCVS Pharmacy, Inc.fbd9086c-39b2-449c-a06d-b85ec7d2dc722026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS Pharmacy, Inc.c5f7741b-1f11-4a34-8f11-de6975c9578d2026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLCVS Pharmacy, Inc.b4238c3a-f6bc-4232-932e-bece539955662026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Latalia Alcohol Antiseptic 80% SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTD2da50235-5d89-4774-9c92-bb22cee081f12026-02-03WarningsExact identifier
application number: M003
Latalia alcohol disinfectant wipesETHYL ALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD4ef3c800-1754-4d9c-81d6-5309db7b04cf2026-02-03WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLDemoulas Super Markets, Inc7cbd8ef5-9744-49ad-9640-d4c2b1ae82032026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Escudo Ultra-Protect OriginalBENZALKONIUM CHLORIDEIndelpa, Inc1cd4c38f-8156-bd74-e063-6394a90a9f562026-02-03WarningsExact identifier
application number: M003
Escudo Ultra-Protect Soft CareBENZALKONIUM CHLORIDEIndelpa, Inc.1cc4b68b-dceb-3fab-e063-6294a90ab1122026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Morning DewALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f60996-6a03-77e0-e063-6394a90a7a112026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Wild Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f64148-5c63-0107-e063-6294a90a0c452026-02-03WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245229benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN458e65f2-826d-4550-8c7d-17add2d7ba9a4
1245229benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD458e65f2-826d-4550-8c7d-17add2d7ba9a4
1245229benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY458e65f2-826d-4550-8c7d-17add2d7ba9a4
1245229benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN35d06b38-55dd-e306-e063-6394a90aaf261
1245229benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD35d06b38-55dd-e306-e063-6394a90aaf261
1245229benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY35d06b38-55dd-e306-e063-6394a90aaf261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-5300-06101053000060 g in 1 BOTTLE, SPRAY (61010-5300-0) 60 g2012-02-150000-00-00NoNoCurrent
61010-5300-26101053000290 g in 1 BOTTLE, SPRAY (61010-5300-2) 90 g2012-02-150000-00-00NoNoCurrent