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 88 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
application number: M003
Easy Care Hand SanitizerALCOHOLGFA Production (Xiamen) Co., Ltd.c7058806-ad4e-6d5f-e053-2a95a90a35e82025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Rejoice International Corp.04fd3bbe-1729-a748-e063-6394a90a96552025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Rejoice International Corp.04fd9665-a6b3-678a-e063-6294a90a60a52025-01-27WarningsExact identifier
application number: M003
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
application number: M003
Germstar Premium Hand SanitizerETHYL ALCOHOLSoaptronic LLC489652af-7333-628a-e054-00144ff8d46c2025-01-24WarningsExact identifier
application number: M003
Little Buddy in a Little TubbyHAND SANITIZING TOWELETTESContinental Research Corpf4fac964-4a27-335d-e053-2a95a90ac4eb2025-01-23WarningsExact identifier
application number: M003
PHARMACYS PRESCRIPTION 8OZ HAND SANITIZERALCOHOLAmerican Consumer Products Corp7a048607-f4c3-6724-e053-2a91aa0ab6f22025-01-23WarningsExact identifier
application number: M003
SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERAALCOHOLAmerican Consumer Products Corpa8f00148-b8fa-6c4f-e053-2995a90ac5e22025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa9ca8aaa-ea76-7eb5-e053-2995a90adef92025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa8c6ef84-b072-72ee-e053-2995a90aa1112025-01-23WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Rejoice International Corp.052031f9-5206-c1bc-e063-6394a90ab0f22025-01-23WarningsExact 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