FDA.reportPublic FDA data

Antiseptic

Product NDC
84269-3501
11-digit product format
842693501
Labeler code
84269
Product ID
84269-3501_544f5843-189c-a04b-e063-6294a90a9b78
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, benzocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
Wildman Business Group
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength
50; 1 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
BENZOCAINE50 mg/g
BENZALKONIUM CHLORIDE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
F5UM2KM3W7Internal 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
1fd15b91-6b81-d0bd-e063-6294a90a4d27Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84269-3501-1Antiseptic60 g in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84269-3501ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [WILDMAN BUSINESS GROUP]1Current NDC, 1 package rows20240901_1fd15b91-6b81-d0bd-e063-6294a90a4d27.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 57 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce569-f2d3-c1e0-e063-6294a90a822f2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1f66d-45f6-bb9a-e063-6394a90a06aa2025-10-26WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLCardinal Healthc95bfab6-bab4-79f3-e053-2995a90a80912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6e97d7-7eea-f7ca-e063-6394a90a4ecd2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6cabf7-9310-cba5-e063-6394a90a3f912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC39529f87-ed4e-52b8-e063-6394a90af8792025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLPhoenix Healthcare Solutions LLCf0b55f6c-4afd-2154-e053-2995a90afcfa2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe8cdf841-cf56-26cc-e053-2995a90aab512025-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLCc17603f2-3548-4225-b611-216c2763e51f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc601d9ea-25ab-cd1d-e053-2995a90ae2522025-10-23WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCardinal Healthcc0a6e1e-ec95-cb48-e053-2a95a90ac0ce2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions, LLCd07d103d-420b-5307-e053-2995a90a14f52025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHtl-Strefa, Inc.d72ddf5a-72e7-c37d-e053-2995a90ad48b2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc92524fd-8b91-592d-e053-2a95a90a88c62025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLCardinal Health89852887-ae62-4277-b615-75663afb54362025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.b9826baa-b976-14c6-e053-2995a90a7d092025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc9261c7f-9f8f-6476-e053-2a95a90a0e932025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLRugby Laboratoriesea28b27a-456e-4042-b769-f060727599332025-10-23WarningsExact identifier
application number: M003
School Health Sterile Alcohol Prep PadISOPROPYL ALCOHOLSchool Health Corporation718640e1-826b-4b65-a021-3f82cd4c983a2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f2025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245229benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN1fd15b91-6b81-d0bd-e063-6294a90a4d271
1245229benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD1fd15b91-6b81-d0bd-e063-6294a90a4d271
1245229benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY1fd15b91-6b81-d0bd-e063-6294a90a4d271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84269-3501-18426935010160 g in 1 BOTTLE, SPRAY60 gHistorical
84269-3501-28426935010260 g in 1 BOTTLE, SPRAY (84269-3501-2) 60 g2026-03-19NoNoCurrent