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 81 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UnguentinePHENOL, ZINC OXIDEOakhurst Company327038a1-b825-1199-e063-6394a90a7f5f2025-04-10WarningsExact identifier
application number: M003
Northside Hospital Grey Amenity KitSODIUM MONOFLUOROPHOSPATEASP Global, LLCa3cc89df-be1b-4d9a-8ba3-8578853254222025-04-09WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)afe23634-27a4-46cf-b428-8fa3a274712c2025-04-09WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)3c70ba1c-b12f-4a98-b993-1179ebe3e0702025-04-09WarningsExact identifier
application number: M003
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDEKenvue Brands LLCd3190050-d646-5957-e053-2995a90ad5212025-04-08WarningsExact identifier
application number: M003
mart Care Assorted Hand Sanitizer 0.94oz-Sweet Pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.322b90e8-be38-7237-e063-6394a90a488f2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c0bdd-4dc5-52e7-e063-6294a90a13802025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c56b0-7eb6-c33a-e063-6394a90a15fb2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.322ce179-c528-0f62-e063-6394a90ac5602025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticHYDROGEN PEROXIDEUltra Distributors Incb6f7b346-3d6b-5953-e053-2995a90a878f2025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact identifier
application number: M003
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
application number: M003
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
application number: M003
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
application number: M003
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
application number: M003
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
application number: M003
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsExact identifier
application number: M003
Sanitizing Hand MistETHYL ALCOHOLALO New York LLC31baefe1-2521-9ef3-e063-6294a90a450e2025-04-01WarningsExact identifier
application number: M003
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
application number: M003
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact 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